| Primary Device ID | 07899995216410 |
| NIH Device Record Key | e08c12ad-4f56-4c56-8597-ef3274281251 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DRIVER HANDPIECE IMP. CM GUIDED Ø3.5 |
| Version Model Number | CTMG 35 |
| Company DUNS | 904569092 |
| Company Name | Sin Sistema de Implante Nacional S/A |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 07899995216410 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
[07899995216410]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-01 |
| Device Publish Date | 2023-12-22 |
| 07899995221179 | DRIVER HANDPIECE IMP. CM GUIDED Ø3.5 |
| 07899995216410 | DRIVER HANDPIECE IMP. CM GUIDED Ø3.5 |