Disposable Hip Instruments 367-01

GUDID 07901125600584

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID07901125600584
NIH Device Record Key10b929ab-99a7-4a7a-9598-d6a1e3f61dc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Hip Instruments
Version Model NumberCAP CUT- CHALLENGE CAPSULE CUTTER
Catalog Number367-01
Company DUNS900865213
Company NameGM DOS REIS INDUSTRIA E COMERCIO LTDA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107901125600584 [Primary]

FDA Product Code

KDDKit, Surgical Instrument, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-06
Device Publish Date2026-01-29

On-Brand Devices [Disposable Hip Instruments]

07901125600614HIP IN - ARTHROSCOPIC HIP ACCESS INSTRUMENT
07901125600607HIP PICK - MICROFRACTURE INSTRUMENT
07901125600591CAP CUT- CURVED CAPSULAR CUTTER
07901125600584CAP CUT- CHALLENGE CAPSULE CUTTER

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