GS System
GUDID 08800000909424
Osstem Implant Co., Ltd.
Dental implant suprastructure, permanent, preformed| Primary Device ID | 08800000909424 |
| NIH Device Record Key | 52a7f9de-4433-4bda-88bc-4b11e69cd43c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GS System |
| Version Model Number | GSTA5641 |
| Company DUNS | 689051793 |
| Company Name | Osstem Implant Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800000909424 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063861
FDA Product Code
| NHA | Abutment, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800000909424]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2015-10-02 |
On-Brand Devices [GS System]
Trademark Results [GS System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GS SYSTEM 79203538 5388853 Live/Registered |
Lonza Ltd. 2016-11-21 |
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