| Primary Device ID | M9935042040 |
| NIH Device Record Key | 39bebee7-d46e-4092-8663-a5cdf6da0c44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GSO GS1 Spacer System |
| Version Model Number | 504204 |
| 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 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M9935042040 [Primary] |
| LRP | Tray, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
Moist Heat or Steam Sterilization
[M9935042040]
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 |
| M9935042040 | Spacer Case |
| M9935042440 | Bone Tap With 1/4" Square QC |
| M9935042430 | Bone Tap With 1/4" Square QC |