GSO GS1 Spacer System

GUDID M9935042430

Bone Tap With 1/4" Square QC

GOLD STANDARD ORTHOPEDICS, LLC

Bone tap, reusable
Primary Device IDM9935042430
NIH Device Record Key8554758b-9af8-4940-acac-99492ab21846
Commercial Distribution StatusIn Commercial Distribution
Brand NameGSO GS1 Spacer System
Version Model Number504243
Company DUNS028008203
Company NameGOLD STANDARD ORTHOPEDICS, LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9935042430 [Primary]

FDA Product Code

HWXTap, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


[M9935042430]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-12-08
Device Publish Date2018-09-21

On-Brand Devices [GSO GS1 Spacer System]

M9935042040Spacer Case
M9935042440Bone Tap With 1/4" Square QC
M9935042430Bone Tap With 1/4" Square QC

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