Primary Device ID | 08800000908281 |
NIH Device Record Key | 0a48a1c2-724f-4cc7-8af0-1b926f8943a2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GS System |
Version Model Number | GSCPL400 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 08800000908281 [Primary] |
NHA | Abutment, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800000908281]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2015-10-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GS SYSTEM 79203538 5388853 Live/Registered |
Lonza Ltd. 2016-11-21 |