| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| 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]
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[M9935097000]
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[M9935097000]
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[M9935097000]
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[M9935097000]
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[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 |