| Primary Device ID | 08800036261305 |
| NIH Device Record Key | 0c3ee6c7-cb83-4567-a1f1-5e09cf2f9547 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bone Cup |
| Version Model Number | BPC06D20 |
| 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 | 08800036261305 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
Moist Heat or Steam Sterilization
[08800036261305]
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 |
| 08800036261343 | BPC10D20 |
| 08800036261336 | BPC09D20 |
| 08800036261329 | BPC08D20 |
| 08800036261312 | BPC07D20 |
| 08800036261305 | BPC06D20 |