| Primary Device ID | 08800041045044 |
| NIH Device Record Key | cd2ea5bf-1759-4e90-9c2c-a20bf0c1976e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SD-Reamer |
| Version Model Number | SD-RM33 |
| Company DUNS | 689846448 |
| Company Name | Surgident 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 | 08800041045044 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
[08800041045044]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-13 |
| Device Publish Date | 2023-03-03 |
| 08800041045051 | SD-RM37 |
| 08800041045044 | SD-RM33 |
| 08800041045037 | SD-RM28 |
| 08800041045020 | SD-RM23 |