Home GUDID 00888912127103 DJO SURGICAL
Primary DI 00888912127103
Brand DJO SURGICAL
Company Encore Medical, L.P.
Model 801-01-014
Device description BROACH ASSEMBLY, TIBIAL, LARGE
Published 2023-04-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name HTQ BROACH
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTQ Broach Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888912127103 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00888912127103 00888912127103 888912127103 0888912127103
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 154074504 Device count 1 Premarket exempt true Lot or batch true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10603295079965 AML EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080176 EXCEL TRI-LOCK DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080183 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080190 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080206 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080213 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080220 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080237 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080244 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080251 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080268 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080275 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080282 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080299 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080305 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080312 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080329 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080336 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080343 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080350 NA DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080367 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080374 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295080381 EXCEL DEPUY ORTHOPAEDICS, INC. HTQ 2018-09-24 10603295082057 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082064 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082071 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082088 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082095 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082101 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24 10603295082118 TRI-LOCK DEPUY (IRELAND) HTQ 2018-09-24