| Primary Device ID | 00810136433456 |
| NIH Device Record Key | b4127f53-6a48-4c8f-b0ed-b46572ca5dd1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptimalTMT™ |
| Version Model Number | 1102.1304.17 |
| Catalog Number | 1102.1304.17 |
| Company DUNS | 126585966 |
| Company Name | Forma Medical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810136433456 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
[00810136433456]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-02 |
| Device Publish Date | 2025-06-30 |
| 00810136433449 | MIS Lapidus Clamp Medial Pad |
| 00810136433463 | Titanium Long MIS Lapidus S-Plate, Right, 4 hole |
| 00810136433456 | Titanium Long MIS Lapidus S-Plate, Left, 4 hole |
| 00810136433487 | LONG MIS Lapidus Targeting Instrument, Right |
| 00810136433470 | LONG MIS Lapidus Targeting Instrument, Left |