GSO ACP1 Anterior Cervical Plate System

GUDID M9935097010

Instrument Case

GOLD STANDARD ORTHOPEDICS, LLC

Instrument tray
Primary Device IDM9935097010
NIH Device Record Keyf0f8f61e-1ae6-4a1a-bee5-020039e5f5cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameGSO ACP1 Anterior Cervical Plate System
Version Model Number509701
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9935097010 [Primary]

FDA Product Code

LRPTray, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


[M9935097010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-10-21
Device Publish Date2018-09-21

On-Brand Devices [GSO ACP1 Anterior Cervical Plate System]

M9935097010Instrument Case
M9935097000Implant Case

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