| Primary Device ID | 08800036261268 |
| NIH Device Record Key | 42e90298-48df-4115-aac4-94495518c2ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bone Pin |
| Version Model Number | BPP07D20 |
| Company DUNS | 557793214 |
| Company Name | Biotem Co., ltd |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800036261268 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
[08800036261268]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-26 |
| Device Publish Date | 2025-08-18 |
| 08800036261299 | BPP10D20 |
| 08800036261282 | BPP09D20 |
| 08800036261275 | BPP08D20 |
| 08800036261268 | BPP07D20 |
| 08800036261251 | BPP06D20 |