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Devices
PenBlade Safety Scalpel
Model / Serial
Product Code PB-M-10, Lots 140901J-A, 150228PB10, 150509PB10, 150510PB10; Product Code PB-M-11P, Lots 140901J-B, 150227PB11, 150318PB11, 150509PB11, 150510PB11; Product Code PB-M-15, Lots 140901J-C, 150226PB15, 150326PB15, 150511PB15, 150512PB15, 150529PB15.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution to U.S. nationwide, Germany and England.
Product Description
PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
Manufacturer
Zien Medical Technologies, Inc
1 Event
Recall of PenBlade Safety Scalpel
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Manufacturer
Zien Medical Technologies, Inc
Manufacturer Address
Zien Medical Technologies, Inc, 2500 S State St, Sted240, Salt Lake City UT 84115-3110
Manufacturer Parent Company (2017)
Zien Medical Technologies Inc.
Source
USFDA
One device with a similar name
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PenBlade Safety Scalpels
Model / Serial
Product Description
Medical instruments for use in humans - general instruments
Manufacturer
ZIEN Medical Technologies
Language
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