| Primary Device ID | 08800041054282 |
| NIH Device Record Key | e96d80fd-85fa-4698-bf44-4973bd3b26d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LATERAL WALL SINUS KIT |
| Version Model Number | ME-TOLA |
| Company DUNS | 689846448 |
| Company Name | Surgident 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 | true |
| 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 | 08800041054282 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
[08800041054282]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-10 |
| Device Publish Date | 2023-10-02 |
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| 08800041065721 - POWERTOME KIT | 2023-11-02 |
| 08800041065738 - Implant Removal Kit Gen II | 2023-11-02 |
| 08800041065745 - Screw Fixation Kit | 2023-11-02 |
| 08800041065752 - Drill Stop Kit | 2023-11-02 |
| 08800041065769 - Shatkin F.I.R.S.T Sinus Lift Kit | 2023-11-02 |
| 08800041065776 - Contra Torque | 2023-11-02 |