Home GUDID 04038653453115 TSPACE
Primary DI 04038653453115
Brand TSPACE
Company Aesculap AG
Model FJ658R
Catalog number FJ658R
Device description TSPACE/PROSPACE OSTEOTOME 8/300MM
Published 2020-06-17
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 04038653453115 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04038653453115 04038653453115 4038653453115
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning 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 [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) 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 315018218 Device count 1 Premarket exempt true Lot or batch 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
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