| Primary Device ID | 00810028397828 |
| NIH Device Record Key | 0ea05df0-5ce1-4d2d-9dc4-8be74f9e82de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Drill Bit, 5.0 x 195mm |
| Version Model Number | DNE-50-150 |
| 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 | 00810028397828 [Primary] |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810028397828]
Moist Heat or Steam Sterilization
[00810028397828]
Moist Heat or Steam Sterilization
[00810028397828]
Moist Heat or Steam Sterilization
[00810028397828]
Moist Heat or Steam Sterilization
[00810028397828]
Moist Heat or Steam Sterilization
[00810028397828]
Moist Heat or Steam Sterilization
[00810028397828]
Moist Heat or Steam Sterilization
[00810028397828]
Moist Heat or Steam Sterilization
[00810028397828]
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 |