| Primary Device ID | 00810028397989 |
| NIH Device Record Key | 0bb8a607-82b7-46d9-9265-4b5099efa28a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pin-to-Bar Double Layer, Thin |
| Version Model Number | 1499-000-002 |
| Company DUNS | 601306413 |
| Company Name | Medshape, 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810028397989 [Primary] |
| FSM | Tray, Surgical, Instrument |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
[00810028397989]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-17 |
| Device Publish Date | 2024-07-09 |
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| M97015000400000 - Eclipse | 2025-08-13 Tendon Spear, ExoShape Tenodesis |
| M97022001100010 - DynaNail | 2025-08-13 Inline Ratchet Driver, DynaNail |
| M97022002900000 - DynaNail | 2025-08-13 FRAME ASSEMBLY, CF, DYNANAIL |
| M97022010900400 - DynaNail | 2025-08-13 Drill, 4.0mm x 15cm, Dynanail |
| M9702300010500 - Eclipse | 2025-08-13 Acorn Reamer, 5.00mm |
| M9702300010550 - Eclipse | 2025-08-13 Acorn Reamer, 5.50mm |