Primary Device ID | M9935097000 |
NIH Device Record Key | 8499220c-edf0-4c04-a160-db6170209cca |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GSO ACP1 Anterior Cervical Plate System |
Version Model Number | 509700 |
Company DUNS | 028008203 |
Company Name | GOLD STANDARD ORTHOPEDICS, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Device Issuing Agency | Device ID |
---|---|
HIBCC | M9935097000 [Primary] |
LRP | Tray, Surgical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
[M9935097000]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-10-21 |
Device Publish Date | 2018-09-21 |
M9935097010 | Instrument Case |
M9935097000 | Implant Case |