FDA.reportPublic FDA data

ENDOTRIG

Primary DI
37613327364102
Brand
ENDOTRIG
Company
Stryker Trauma SA
Model
1052-6
Catalog number
1052-6
Device description
Hook Blade
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBHACCESSORIES,ARTHROSCOPIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327364102PackageGS16In Commercial Distribution
07613327364101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332736410237613327364102
07613327364101076133273641017613327364101

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel blade, single-useA sterile interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481999654
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327667738NASIT0006000SIT00060002025-03-28
07613327084191STEINMANN3593-1-0903593-1-0902025-01-09
07613327614633PANGEA5420045420042024-12-01
07613327624786PANGEA542110S542110S2024-12-01
07613327624809PANGEA5421125421122024-12-01
07613327624816PANGEA5421375421372024-12-01
07613327624830PANGEA5421855421852024-12-01
07613327624847PANGEA5421385421382024-12-01
07613327624861PANGEA5421185421182024-12-01
07613327624878PANGEA5421365421362024-12-01
07613327624885PANGEA5421195421192024-12-01
07613327624908PANGEA5421325421322024-12-01
07613327624915PANGEA542130S542130S2024-12-01
07613327624939PANGEA5421395421392024-12-01
07613327624977PANGEA5421725421722024-12-01
07613327624984PANGEA5421545421542024-12-01
07613327624991PANGEA5421205421202024-12-01
07613327625011PANGEA542132S542132S2024-12-01
07613327625028PANGEA5421135421132024-12-01
07613327625035PANGEA5421865421862024-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417918MillenniumAvalign Technologies, Inc.NBH2026-03-23
00190776417949MillenniumAvalign Technologies, Inc.NBH2026-03-23
00190776418267MillenniumAvalign Technologies, Inc.NBH2026-03-23
B382SD18129DK0Surgical DirectSurgical Direct, Inc.NBH2026-03-09
B382SD316590Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD316790Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD9156321000Surgical DirectSurgical Direct, Inc.NBH2026-02-26
00190776416386MillenniumAvalign Technologies, Inc.NBH2026-02-16
04055207068243VERTEBRISRichard Wolf GmbHNBH2026-02-10
04055207069691NARichard Wolf GmbHNBH2026-02-10
04055207069707NARichard Wolf GmbHNBH2026-02-10
04055207069714NARichard Wolf GmbHNBH2026-02-10
04055207069721NARichard Wolf GmbHNBH2026-02-10
04055207069738NARichard Wolf GmbHNBH2026-02-10
04055207069745NARichard Wolf GmbHNBH2026-02-10
B382SD181290Surgical DirectSurgical Direct, Inc.NBH2026-02-06
10748426142719Arthrex®Microtek Medical LLCNBH2026-02-02
07630542726620SportMeds InstrumentsMedacta International SANBH2026-01-30
00888867516144Arthrex®ARTHREX, INC.NBH2026-01-28
00888867516168Arthrex®ARTHREX, INC.NBH2026-01-28
07630542703683SportMeds InstrumentsMedacta International SANBH2026-01-21
00812231034170ZEOSSANTA BARBARA IMAGING SYSTEMS, INC.NBH2026-01-19
00812231034941ZEOSSANTA BARBARA IMAGING SYSTEMS, INC.NBH2026-01-19
00198506087622ELMED INCORPORATEDELMED INCORPORATEDNBH2026-01-16
04055207069790NARichard Wolf GmbHNBH2026-01-14
04055207069806NARichard Wolf GmbHNBH2026-01-14
04055207069813NARichard Wolf GmbHNBH2026-01-14
04055207069820NARichard Wolf GmbHNBH2026-01-14
04055207069837NARichard Wolf GmbHNBH2026-01-14
04055207069851NARichard Wolf GmbHNBH2026-01-14