| Primary Device ID | 08800271260316 |
| NIH Device Record Key | 82fd5855-9d23-4b52-95d8-0ebe3d8b8268 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TAPER KIT |
| Version Model Number | HKTAPEK |
| 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 | true |
| 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 | 08800271260316 [Primary] |
| NYE | Fixture Mount Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
[08800271260316]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-15 |
| Device Publish Date | 2025-09-05 |
| 08809917147387 | HTAPEK |
| 08800040608615 | OTSK |
| 08809917158871 | HKTAPEK |
| 08809917108586 | HTAPEK |
| 08809917070074 | OTSK |
| 08800271260316 | HKTAPEK |