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Manufacturers
Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217
Manufacturer Parent Company (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA
3 Events
Recall of GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; || GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; || GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; || GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; || GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; || GE626SU; HI-LINE XS DISP.DIAM.BURR X-CRS.III D4.5;
Recall of GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; || GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; || GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; || GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; || GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0;
Recall of GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; || GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; || GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; || GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; || GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; || GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; || GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; || GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; || GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; || GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; || GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; || GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; || GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; || GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; || GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; || GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; || GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0;
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3 devices in the database
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; || GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4....
Model / Serial
Model numbers: GE426R ; GE426SU ; GE526R ; GE526SU ; GE626R ; GE626SU ;
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
CA, IL, NY, PA, TN, TX
Product Description
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; || GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; || GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; || GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; || GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; || GE626SU; HI-LINE XS DISP.DIAM.BURR X-CRS.III D4.5;
GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; || GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0...
Model / Serial
Model numbers: GP321R ; GP322R ; GP323R ; GP324R ; GP325R ;
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
CA, IL, NY, PA, TN, TX
Product Description
GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; || GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; || GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; || GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; || GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0;
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2....
Model / Serial
Model numbers COARSE: GP161R ; GP162R ; GP163R ; GP164R ; GP165R ; GP166R ; GP167R ; GP168R ; GP169R ; GP170R ; Model numbers X-Course: GP173R ; GP174R ; GP175R ; GP176R ; GP177R ; GP328R ; GP329R ; GP330R ;
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
CA, IL, NY, PA, TN, TX
Product Description
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; || GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; || GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; || GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; || GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; || GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; || GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; || GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; || GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; || GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; || GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; || GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; || GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; || GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; || GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; || GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; || GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0;
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