FDA.reportPublic FDA data

DePuy Synthes

Primary DI
00817766025600
Brand
DePuy Synthes
Company
Tecomet
Model
Thoracolumbar Bit Tray
Catalog number
TY10005
Device description
Thoracolumbar Bit Tray, Stainless Steel
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817766025600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817766025600008177660256008177660256000817766025600

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118087931
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817766026461Case 2 Complete2500-00-7942023-09-22
00817766026249Smith & Nephew Tray - Offset Cup Impactor Lid33000206-35122020-05-14
00817766026348Smith & Nephew Tray - Offset Cup Impactor Base33000306-35132020-05-14
00817766024863KARL STORZ04-1268-US04-1268-US2019-12-12
00817766024870KARL STORZ05-327505-32752019-12-12
00817766024887KARL STORZKSE09007KSE090072019-12-12
00817766024900KARL STORZKSE09006KSE090062019-12-12
00817766024931KARL STORZKSE09024KSE090242019-12-12
00817766024948KARL STORZKSE09044KSE090442019-12-12
00817766024979KARL STORZKSE09015KSE090152019-12-12
00817766024986KARL STORZKSE09016KSE090162019-12-12
00817766024993KARL STORZKSE09022KSE090222019-12-12
00817766025006KARL STORZKSE09023KSE090232019-12-12
00817766025020KARL STORZKSE09013-USKSE09013-US2019-12-12
00817766025044KARL STORZKSE09017KSE090172019-12-12
00817766025068KARL STORZKSE09012KSE090122019-12-12
00817766025075KARL STORZKSE09011KSE090112019-12-12
00817766025082KARL STORZKSE09030KSE090302019-12-12
00817766025099KARL STORZKSE09020KSE090202019-12-12
0081776602510500817766025105KSE09021KSE090212019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
00840456201299JMUJMU DENTAL, INCFRG2026-06-05
00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00840456201862JMUJMU DENTAL, INCFRG2026-06-05
00840456201879JMUJMU DENTAL, INCFRG2026-06-05
00840456201886JMUJMU DENTAL, INCFRG2026-06-05
00840456201893JMUJMU DENTAL, INCFRG2026-06-05
00840456201909JMUJMU DENTAL, INCFRG2026-06-05
00840456201916JMUJMU DENTAL, INCFRG2026-06-05
00840456201923JMUJMU DENTAL, INCFRG2026-06-05
00840456201930JMUJMU DENTAL, INCFRG2026-06-05
00840456201947JMUJMU DENTAL, INCFRG2026-06-05
00840456202951JMUJMU DENTAL, INCFRG2026-06-05
00840456202968JMUJMU DENTAL, INCFRG2026-06-05
00840456202975JMUJMU DENTAL, INCFRG2026-06-05
00840456202982JMUJMU DENTAL, INCFRG2026-06-05
00840456202999JMUJMU DENTAL, INCFRG2026-06-05
00840456207208JMUJMU DENTAL, INCFRG2026-06-05
00840456207215JMUJMU DENTAL, INCFRG2026-06-05
00840456215180JMUJMU DENTAL, INCFRG2026-06-05
00840456215197JMUJMU DENTAL, INCFRG2026-06-05
00840456215203JMUJMU DENTAL, INCFRG2026-06-05
00840456216804JMUJMU DENTAL, INCFRG2026-06-05
00840456216811JMUJMU DENTAL, INCFRG2026-06-05
00840456216828JMUJMU DENTAL, INCFRG2026-06-05