| Primary Device ID | 03701505800139 |
| NIH Device Record Key | 115a9006-d24d-4253-b11f-4ca249227a0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ratchet Handle |
| Version Model Number | T067228 |
| Catalog Number | T067228 |
| Company DUNS | 764746723 |
| Company Name | TEKNIMED |
| 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 | 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 | 03701505800139 [Primary] |
| HXX | Screwdriver |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
[03701505800139]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-30 |
| Device Publish Date | 2024-01-22 |
| 03760177040090 - GENTAFIX | 2025-09-10 |
| 03760177040137 - GENTAFIX | 2025-09-10 |
| 03760177043176 - GENTAFIX | 2025-09-10 |
| 03701505801020 - PureKit Syringe 1.5cc MV | 2025-04-08 |
| 03701505801037 - META+ System 1.5cc MV | 2025-04-08 |
| 03701505801075 - PUREKIT Syringes | 2025-04-08 |
| 03701505801082 - Syringes 4cc | 2025-04-08 |
| 03701505801099 - Syringes 1.5cc | 2025-04-08 |