| Primary Device ID | 00810028397897 |
| NIH Device Record Key | aeb3d3a0-8c7a-4da6-b54e-77845e97aec2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tensioner Extender |
| Version Model Number | DNE-9000-TE |
| 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 | 00810028397897 [Primary] |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810028397897]
Moist Heat or Steam Sterilization
[00810028397897]
Moist Heat or Steam Sterilization
[00810028397897]
Moist Heat or Steam Sterilization
[00810028397897]
Moist Heat or Steam Sterilization
[00810028397897]
Moist Heat or Steam Sterilization
[00810028397897]
Moist Heat or Steam Sterilization
[00810028397897]
Moist Heat or Steam Sterilization
[00810028397897]
Moist Heat or Steam Sterilization
[00810028397897]
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 |