| Primary Device ID | 08800000952017 |
| NIH Device Record Key | 2e0dc9f7-fee6-4cdb-b55c-7952dec2a21c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trephine Drill |
| Version Model Number | TD42 |
| Company DUNS | 689051793 |
| Company Name | Osstem Implant 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 | true |
| 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 | 08800000952017 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
[08800000952017]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-04-03 |
| Device Publish Date | 2022-12-08 |
| 08809917071408 | TD62 |
| 08809917071392 | TD62S |
| 08809917071385 | TD57 |
| 08809917071378 | TD57S |
| 08809917071361 | TD52 |
| 08809917071354 | TD52S |
| 08809917071347 | TD47 |
| 08809917071330 | TD47S |
| 08809917071323 | TD42 |
| 08809917071316 | TD42S |
| 08809917071309 | TD37 |
| 08809917071293 | TD37S |
| 08800209373088 | HTD62S |
| 08800209373071 | HTD62 |
| 08800209373064 | HTD57S |
| 08800209373057 | HTD57 |
| 08800209373040 | HTD52S |
| 08800209373033 | HTD52 |
| 08800209373026 | HTD47S |
| 08800209373019 | HTD47 |
| 08800209373002 | HTD42S |
| 08800209372999 | HTD42 |
| 08800209372982 | HTD37S |
| 08800209372975 | HTD37 |
| 08800040612414 | TD57 |
| 08800000961323 | TD57S |
| 08800000952109 | TD62S |
| 08800000952093 | TD62 |
| 08800000952079 | TD52S |
| 08800000952062 | TD52 |
| 08800000952055 | TD47S |
| 08800000952048 | TD47 |
| 08800000952024 | TD42S |
| 08800000952017 | TD42 |
| 08800000951591 | TD37S |
| 08800000951584 | TD37 |