| Primary Device ID | 08800016161588 |
| NIH Device Record Key | dcfbabcc-aca3-4de8-9f01-6cacb86542b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spreader Handle |
| Version Model Number | 2SMSFSP01H |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800016161588 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
[08800016161588]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-05 |
| Device Publish Date | 2026-01-28 |
| 08800016163063 | SSFSP01HN |
| 08800016161588 | 2SMSFSP01H |
| 08800016161564 | 2SSFSP01H |