| Primary Device ID | 08800070226247 |
| NIH Device Record Key | df90583e-47b6-4a5d-a0a3-290d3af96f2c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Drill Stopper |
| Version Model Number | TDDS11G |
| 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 | 08800070226247 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800070226247]
Moist Heat or Steam Sterilization
[08800070226247]
Moist Heat or Steam Sterilization
[08800070226247]
Moist Heat or Steam Sterilization
[08800070226247]
Moist Heat or Steam Sterilization
[08800070226247]
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 |
| 08800070226261 | TDDS15P |
| 08800070226254 | TDDS13B |
| 08800070226247 | TDDS11G |
| 08800070226230 | TDDS10Y |
| 08800070226223 | TDDS08P |
| 08800070226216 | TDDS07B |
| 08800070226209 | TDDS06G |
| 08800070226193 | TDDS05Y |
| 08800070226186 | TDDS04P |
| 08800070226179 | TDDS03B |
| 08800070237199 | TDDSM15P |
| 08800070237182 | TDDSM13B |
| 08800070237175 | TDDSM11G |
| 08800070237168 | TDDSM10Y |
| 08800070237151 | TDDSM08P |