| Primary Device ID | 08800070225004 |
| NIH Device Record Key | d555b018-f559-4ba5-aa13-708113f4473c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Twist Drill |
| Version Model Number | TD2F46S |
| Company DUNS | 694625347 |
| Company Name | Izenimplant Co., Ltd. |
| 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 | 08800070225004 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800070225004]
Moist Heat or Steam Sterilization
[08800070225004]
Moist Heat or Steam Sterilization
[08800070225004]
Moist Heat or Steam Sterilization
[08800070225004]
Moist Heat or Steam Sterilization
[08800070225004]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-24 |
| Device Publish Date | 2022-05-16 |
| 08800070225011 | TD2F46L |
| 08800070225004 | TD2F46S |
| 08800070224991 | TD2F41L |
| 08800070224984 | TD2F41S |
| 08800070224977 | TD2F36L |
| 08800070224960 | TD2F36S |
| 08800070224953 | TD2F30L |
| 08800070224946 | TD2F30S |
| 08800070224939 | TD2F27L |
| 08800070224922 | TD2F27S |
| 08800070224915 | TD2F25L |
| 08800070224908 | TD2F25S |
| 08800070224892 | TD2F22L |
| 08800070224885 | TD2F22S |
| 08800070237144 | TDM2F30L |
| 08800070237137 | TDM2F27L |
| 08800070237120 | TDM2F25L |
| 08800070237113 | TDM2F22L |