| Primary Device ID | M9935042430 |
| NIH Device Record Key | 8554758b-9af8-4940-acac-99492ab21846 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GSO GS1 Spacer System |
| Version Model Number | 504243 |
| 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 | false |
| 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 |
| 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 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | M9935042430 [Primary] |
| HWX | Tap, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[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
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-12-08 |
| 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 |