Angiotech Access Needle

  • Model / Serial
    A) 90851TFD, 91131TZ5, 90571SUT, 91041TT1, 91401UJV, 90821TC4 , 90821TC5, 90831TDL, 90961TMO, 91131TZG , 91131U0E, 91331UCU, 90621T0B, 90631T0V, 90761T8P, 90921TKS, 90921TKT, 90961TM0, 91131TY3, 91201U5R , 91271U9U, 91331UCT, 91461UMS, 91821VDN.   B) 90471SM2, 90541SRA, 90681T3G, 90751T6V, 91031TS5, 91331UBZ, 90751T79, 90751T7A, 90481SNV, 90541SRC, 90571SUN, 90621SZK, 90771T9K, 90821TCF, 90851TFK, 90901TIR, 90971TOS, 91041TST, 91041TSU, 91271U9B, 91311UAU, 91311UAV, 91311UAW, 91341UEW, 91341UEX, 91531UQI, 91531UQJ, 91621UZ1, 91631UZK, 90471SMB, 90541SS8, 90751T7J, 90841TEF, 90971TO5, 91181U2P, 90781TBC, 90831TE6, 91031TSI, 90851TFF.   C) 90551STL, 91381UGK, 91891VI3, 91891VI4, 91891VI5 .   D) 90471SMA, 90481SNT, 90481SNW, 90541SS3, 90541SSP, 90551STJ, 90571SUL, 90571SWE, 90611SXU, 90611SYF, 90621SZM, 90631T14, 90681T3U, 90691T4N, 90701T59, 90701T5E, 90701T5K, 90751T6W, 90751T71, 90751T76, 90751T78, 90751T7C, 90751T7I, 90751T7N, 90751T88, 90761T8H, 90761T8L, 90761T8M, 90761T8S, 90771TAS, 90781TB6, 90821TD1, 90831TDR, 90831TE7, 90891TFE, 90891TGQ, 90901TIG, 90901TIH, 90901TIQ, 90921TL2, 90961TM44, 90961TM7, 90971TNE, 90971TO2, 90971TOO, 90971TOQ, 90971TOR, 90981TPS, 90981TQG, 90991TNF, 90991TR1, 90991TR2, 90991TRD, 91031TRZ, 91041TSX, 91041TSY, 91111TWA, 91111TWG, 91131TZ6, 91131TZF, 91131U09, 91131U0G, 91131U0O, 91171U24, 91181TW1, 91181U33, 91181U34, 91181U35, 91191TW4, 91191TW6, 91191U44, 91191U45, 91191U4Q, 91201U5M, 91201U5N, 91271U9N, 91271U9W, 91331UCO, 91341UF4, 91401UIU, 91401UIZ, 91401UJ4, 91401UJA, 91401UJH, 91401UJQ, 91401UJU, 91471UNN, 91481UO8, 91481UOD, 91491UP9, 91531UQK, 91561UUH, 91591UV7, 91631UZI, 91681V2F, 91681V2G, 91681V2H, 91681V2P, 91731V61, 91741V7R, 91761V9C, 91761V9Q, 91801VCB, 91801VCC, 91801VCD, 91801VBM, 90551STY, 90551STZ, 90571SWG, 90611SXI, 90641T15, 90701T5L, 90751T7M, 90751T7P, 90781TBG, 90781TBU, 90851TFI, 90921TL5, 90961TM9, 90971TOT, 90981TQ3, 91041TQ2, 91271U9D, 91271U9E, 91331UC8, 91331UCG, 91331UCS, 91341UEP, 91341UFI, 91561UTV, 91611UYB, 91701V4Q, 91701V4R, 91801VCE.
  • Product Classification
  • 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 Access Needle. || A) Hawkins Blunt Needle. STERILE. Product Number: 216057, 216107, 218057, 218107, 218157. 510k K881957. Qty Dist. - 3,220. || B) Winged Guidewire Introducer Needle, Guidewire Introducer Needle, and "WW" Guidewire Introducer Needle. STERILE. Product Number: BGWI1802, BGWI1902, GWI1802, GWI1802WW, GWI1902. GWI1902WW. 510k K974745. Qty Dist: - 51,625. || C) Introducer Sheath Needle. STERILE. Product Number: ISN1915. 510k Exempt. Qty Dist: - 1,260. || D) Co-Axial Introducer Needle, and Co-Axial Needle - Biopince. STERILE. Product Number: MCXS1408SX, MCXS1409LX, MCXS1410AX, MCXS1410MX, MCXS1410TX, MCXS1412SX, MCXS1415LX, MCXS1416AX, MCXS1609LX, MCXS1610AX, MCXS1610TX, MCXS1612SX, MCXS1615LX, MCXS1616AX, MCXS1616MX, MCXS1616TX, MCXS1808SX, MXCS1809LX, MCXS1810AX, MCXS1810TX, MCXS1812SX, MCXS1815LX, MCXS1816AX, MCXS1816MX, MCXS1816SX, MCXS1816TX, MCXS1820AX, MCXS1820LX, MCXS2009LY, MCXS2010AY, MCXS2010MY, MCXS2010TY, MCXS2012SY, MCXS2015LY, MCXS2016AY, MCXS2016MY, MCXS2016SY, MCXS2016TY, MCXS1610BP, MCXS1615BP, MCXS1810BP, MCXS1815BP, MCXS1820BP. 510k K980004. Qty Dist: - 48,448. || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. || Intended Use: Access Needle
  • Manufacturer
  • 1 Event

Manufacturer

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