Golden Spike 21-5L-INS1
GUDID 00843511101343
Golden Spike Tapered Inserter
OMNIA MEDICAL, LLC
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 00843511101343 |
| NIH Device Record Key | ff507a73-c223-4194-95fe-899fc1ad3912 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Golden Spike |
| Version Model Number | 21-5L-INS1 |
| Catalog Number | 21-5L-INS1 |
| Company DUNS | 079467378 |
| Company Name | OMNIA MEDICAL, 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843511101343 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
[00843511101343]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-27 |
| Device Publish Date | 2020-07-17 |
On-Brand Devices [Golden Spike]
| 00843511100742 | 4.5 x 45mm Trauma Screw |
| 00843511100735 | 4.5 x 40mm trauma screw |
| 00843511101343 | Golden Spike Tapered Inserter |
| 00843511122881 | 4.5 x 45mm Threaded Trauma Screw |
| 00843511122874 | 4.5 x 40mm threaded trauma screw |
Trademark Results [Golden Spike]
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