Devices

Angiotech Soft Tissue Biopsy Needle Core

Model / Serial
A) 90831TDP, 90541SSA, 90501SQH, 90851TFJ, 91191U4R, 91391UI0, 90751T73, 91391UHQ, 90771T9L, 90851TFL, 90551SU0, 90551SU1, 90611SYJ, 90761T8Y, 90771TAH, 90781TBL, 90831TDY, 90911TK9, 91121TWT, 91271UA6, 91341UET, 91391UHN, 91481UNX, 91491UPN, 91661V0I, 91691V3D, 91761V94, 90541SSM, 90551STX, 90681T3H, 90701T58, 91171U1C, 91321UAQ, 91481UNY, 91821VDX, 90751T7Z, 90831TDW, 90991TR4, 90991TR5, 91031TR6, 91321UB8, 91661V0O, 90481SO1, 90621T04, 90621T05, 90901TJ7, 91121TY1, 91131U0J, 91171U1V, 91381UH2. B) 90541SRD, 90611SXP, 90981TQ5, 90971TNX, 90971TO1. C) 90551STO, 90681T40, 90821TCS, 90901TIY, 90911TK8, 91261U8B, 91261U8C, 91271U9A, 91381UGH, 91821VDG, 91821VDH, 91821VDI, 91821VDJ, 90771TA7, 90781TB2, 91181U2M, 90501SQI, 90921TKO, 90761T8U, 90901TIN, 91181U32, 91401UJ9, 91741V7S . D) 91271U9J, 90681T31.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.
Product Description
Angiotech Soft Tissue Biopsy Needle Core: || A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. || Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. || B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. || C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. || D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. || Intended use: Soft Tissue Biopsy Needle Core
Manufacturer
Medical Device Technologies, Inc.
1 Event
- Recall of Angiotech Soft Tissue Biopsy Needle Core

Manufacturer

Medical Device Technologies, Inc.

Manufacturer Address
Medical Device Technologies, Inc., 3600 Sw 47th Ave, Gainesville FL 32608-7555
Manufacturer Parent Company (2017)
RoundTable Healthcare Partners Lp
Source
USFDA

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