| Primary Device ID | 08809471726479 |
| NIH Device Record Key | 91ca8e91-3d10-452d-a1a3-cedbaf117b08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dental Surgical Kit |
| Version Model Number | KSA001 |
| Company DUNS | 688753763 |
| Company Name | Cowellmedi 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 | 08809471726479 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
[08809471726479]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-15 |
| Device Publish Date | 2024-08-07 |
| 08809471726554 | KBT001 |
| 08809471726523 | KSI001 |
| 08809471726516 | KCA010FE |
| 08809471726509 | KCA010FI |
| 08809471726493 | KCA010F |
| 08809471726486 | KSA002 |
| 08809471726479 | KSA001 |
| 08809471726462 | KPA003 |
| 08800016161007 | KCA010FH |
| 08800016121964 | KPA004 |
| 08800016114997 | KIPP001 |
| 08800016112610 | KIGICS |
| 08800016109726 | KIGBR001 |
| 08800016107203 | KLSP001 |
| 08800016106824 | KIAH001 |
| 08800016106688 | KLS001 |
| 08800016103960 | KAE001 |
| 08800016103953 | KDSG002 |
| 08800016103625 | KHA001 |
| 08800016103618 | KSA004 |
| 08800016103113 | KNA001 |
| 08800016176735 | KHA002 |
| 08800016172188 | KPF001 |
| 08800016169072 | KBP001 |
| 08800016163230 | KLSS001 |