| Primary Device ID | 00857915007613 |
| NIH Device Record Key | cc4097ed-d7a1-49c3-834b-72dd62850940 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LITE HIGH PROFILE |
| Version Model Number | 3650 |
| Company DUNS | 160020087 |
| Company Name | A.M. SURGICAL, INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857915007613 [Primary] |
| GS1 | 00857915007620 [Package] Package: Case [5 Units] In Commercial Distribution |
| NBH | Accessories, Arthroscopic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-19 |
| Device Publish Date | 2021-01-11 |
| 10857915007191 - Secure Screw 40mm | 2021-02-17 Secure Screw 40mm |
| 00857915007248 - Secure Screw 45mm | 2021-02-17 Secure Screw 45mm |
| 10857915007214 - Secure Screw 50mm | 2021-02-17 Secure Screw 50mm |
| 00857915007255 - Secure Screw 55mm | 2021-02-17 Secure Screw 55mm |
| 10857915007238 - Secure Screw 60mm | 2021-02-17 Secure Screw 60mm |
| 00857915007262 - Secure Screw Starter Pack | 2021-02-17 Secure Screw Starter Pack |
| 10857915007566 - Secure Screw 35mm | 2021-02-17 Secure Screw 35mm |
| 00857915007606 - PARA CPX | 2021-01-19 PARA Cross Pin External Fixation Frame and One Tightening Tool |