FDA.reportPublic FDA data

Tensor

Primary DI
00810041637772
Brand
Tensor
Company
Provision
Model
3020
Published
2019-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810041637772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041637772008100416377728100416377720810041637772

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reprocessedA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
016889401
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B504OMBMAS90006S0BrasselerBMA-S90006S2026-10-20
B504OMBMAS90007S0BrasselerBMA-S90007S2026-10-20
B504OMBMAS90008S0BrasselerBMA-S90008S2026-10-20
B504OMBMLS900040BrasselerBML-S900042026-10-20
B504OMBR2544001110BrasselerBR2544-00-1112026-10-20
B504OMBR9505023020BrasselerBR9505-02-3022026-10-20
B504OMBR9505023030BrasselerBR9505-02-3032026-10-20
B504OMDP86011710BrasselerDP86-0117-12026-10-20
B504OMST60070031000BrasselerST6007-003-1002026-10-20
B504OMST60070031500BrasselerST6007-003-1502026-10-20
B504OMST60071031100BrasselerST6007-103-1102026-10-20
B504OMST60071041500BrasselerST6007-104-1502026-10-20
B504OMZB005901020000BrasselerZB00-5901-020-002026-10-20
B504GS80200Vericel80202026-07-20
B504GS80210Vericel80212026-07-20
B504GS80220Vericel80222026-07-20
B504OM19S17050Brasseler19-S17052026-07-20
B504OM22963414S70Stryker2296-3-414S72026-07-20
B504OM3162880Synthes316.2882026-07-20
B504OM4058830Biomet4058832026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434786MillenniumAvalign Technologies, Inc.HWJ2026-10-12
00643169524699Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-09-20
04054896000770AwlSilony Medical GmbHHWJ2026-09-18
04054896000787AwlSilony Medical GmbHHWJ2026-09-18
04054896002927AwlSilony Medical GmbHHWJ2026-09-18
04054896005553AwlSilony Medical GmbHHWJ2026-09-18
04054896005560AwlSilony Medical GmbHHWJ2026-09-18
04054896005577AwlSilony Medical GmbHHWJ2026-09-18
04054896014999AwlSilony Medical GmbHHWJ2026-09-18
04054896015002AwlSilony Medical GmbHHWJ2026-09-18
04054896021669AwlSilony Medical GmbHHWJ2026-09-18
04054896024288AwlSilony Medical GmbHHWJ2026-09-18
04054896024295AwlSilony Medical GmbHHWJ2026-09-18
04054896024301AwlSilony Medical GmbHHWJ2026-09-18
04054896024318AwlSilony Medical GmbHHWJ2026-09-18
04054896032818AwlSilony Medical GmbHHWJ2026-09-18
04054896052595AwlSilony Medical GmbHHWJ2026-09-18
04054896052601AwlSilony Medical GmbHHWJ2026-09-18
04054896056777AwlSilony Medical GmbHHWJ2026-09-18
04054896069289AwlSilony Medical GmbHHWJ2026-09-18
04054896079325AwlSilony Medical GmbHHWJ2026-09-18
04054896079332AwlSilony Medical GmbHHWJ2026-09-18
04054896079349AwlSilony Medical GmbHHWJ2026-09-18
04054896079356AwlSilony Medical GmbHHWJ2026-09-18
04054896079363AwlSilony Medical GmbHHWJ2026-09-18
04054896079370AwlSilony Medical GmbHHWJ2026-09-18
04054896079387AwlSilony Medical GmbHHWJ2026-09-18
04054896079394AwlSilony Medical GmbHHWJ2026-09-18
04054896079578AwlSilony Medical GmbHHWJ2026-09-18
04054896079585AwlSilony Medical GmbHHWJ2026-09-18