| Primary Device ID | M9935042140 | 
| NIH Device Record Key | 9ab6059f-05f4-441a-94ff-7d813fb50581 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | GSO GS1 Spinal System | 
| Version Model Number | 504214 | 
| 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 | M9935042140 [Primary] | 
| HWX | Tap, Bone | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
Moist Heat or Steam Sterilization
[M9935042140]
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 | 
| M9935081510 | Inserter | 
| M9935042640 | Nav Compatible Bone Tap W/1/4" Quick Connect 7.0mm Bone Tap | 
| M9935042630 | Nav Compatible Bone Tap W/1/4" Quick Connect 6.25mm Bone Tap | 
| M9935042620 | Nav Compatible Bone Tap W/1/4" Quick Connect 5.5mm Bone Tap | 
| M9935042230 | Nav Compatible Probe | 
| M9935041630 | Navigation Screw Inserter Assembly | 
| M9935082110 | Rod Holder Fixed | 
| M993507155140 | 14mm Drill Guide Extension | 
| M9935042110 | Rod Holder | 
| M9935041710 | Hook Holder | 
| M9935082030 | Implant Case | 
| M9935082020 | Screw Caddy | 
| M9935082010 | Instrument Case | 
| M9935042030 | Instrument Case | 
| M9935042020 | Instrument Case | 
| M9935042010 | Implant Case | 
| M9935041700 | Hook Implant Instrument Case | 
| M9935082460 | Cannulated Awl | 
| M9935042060 | Bone Awl | 
| M9935082430 | Cannulated Bone Tap With 1/4" Square QC | 
| M9935082420 | Cannulated Bone Tap With 1/4" Square QC | 
| M9935042420 | Bone Tap With 1/4" Square QC | 
| M9935042140 | Bone Tap | 
| M9935042130 | Bone Tap | 
| M9935042120 | Bone Tap |