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
07613327072631NA3901823901822021-10-27
37613327072670VARIAX7038187038182016-09-22
33700586902351AUTOFIX451-0031451-00312015-09-24
33700586903464AUTOFIX451-1136451-11362015-09-24
37613327356503ENDOTRIG106010602018-09-24
37613327362214EDINTRAK406040602017-05-30
37613327072403HOFFMANN4922-1-0024922-1-0022016-09-24
37613327072427HOFFMANN4922-1-0034922-1-0032016-09-24
37613327072687HOFFMANN4922-1-0064922-1-0062016-09-24
37613327072694HOFFMANN4922-1-0074922-1-0072016-09-24
37613154639497NA52-0080452-008042018-09-24
37613154639503NA52-0090452-009042018-09-24
37613154639510NA52-0100452-010042018-09-24
37613154639527NA52-0110552-011052018-09-24
37613154639534NA52-0120452-012042018-09-24
37613154639541NA52-0120552-012052018-09-24
37613154639558NA52-0130452-013042018-09-24
37613154639565NA52-0130652-013062018-09-24
37613154639572NA52-0140452-014042018-09-24
37613154639589NA52-0140652-014062018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427160MillenniumAvalign Technologies, Inc.NBH2026-08-21
00190776427177MillenniumAvalign Technologies, Inc.NBH2026-08-21
00198506094170ELMED INCORPORATEDELMED INCORPORATEDNBH2026-08-18
07630345716743SportsMed InstrumentsMedacta International SANBH2026-08-17
07630345716750SportsMed InstrumentsMedacta International SANBH2026-08-17
B382SD319590Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD480084LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD48008SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481014SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481022LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752CBDYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752PT0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481755STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481756STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481760DYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD483003STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487193000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487223000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD5235320Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD142090Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD1814DK70Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD18252590Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD30609CH0Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD316390Surgical DirectSurgical Direct, Inc.NBH2026-07-31
00198506093258ELMED INCORPORATEDELMED INCORPORATEDNBH2026-07-28
00810143908534SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909449SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909456SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909463SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909470SURGIPROSSurgipros, LLCNBH2026-07-28