Home GUDID 00888912098113 DJO SURGICAL
Primary DI 00888912098113
Brand DJO SURGICAL
Company DJO, LLC
Model 803-61-022
Device description MODULAR BOX OSTEOTOME
Published 2023-09-19
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 HWM OSTEOTOME
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWM Osteotome General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888912098113 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 00888912098113 00888912098113 888912098113 0888912098113
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant inserter/extractor, reusable A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081840873 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 09348811099624 INKA The Trustee for KAISER FAMILY TRUST HWM 2026-03-18 09348811110442 INKA The Trustee for KAISER FAMILY TRUST HWM 2026-03-18 09348811111289 INKA The Trustee for KAISER FAMILY TRUST HWM 2026-03-18 10381780503316 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503323 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503330 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503347 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10381780503354 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HWM 2020-10-01 10603295080770 NA DEPUY (IRELAND) HWM 2018-09-24 10603295080787 NA DEPUY (IRELAND) HWM 2018-09-24 10603295080794 NA DEPUY (IRELAND) HWM 2018-09-24 10603295083160 SIGMA DEPUY (IRELAND) HWM 2018-09-24 10603295083191 SIGMA DEPUY (IRELAND) HWM 2018-09-24 10603295090403 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295090410 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295090427 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295090434 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295090441 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295090458 GLOBAL AP DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295122739 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122746 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122753 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122760 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122777 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122784 NA DEPUY (IRELAND) HWM 2018-09-24 10603295122791 NA DEPUY (IRELAND) HWM 2018-09-24 10603295123071 MORELAND DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295123088 MORELAND DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295123095 MORELAND DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24 10603295123101 MORELAND DEPUY ORTHOPAEDICS, INC. HWM 2018-09-24