Primary Device ID | 08809917098702 |
NIH Device Record Key | b0d655bb-ce8e-47fe-8eb3-b0b12d578c90 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OneGuide KS Implant Driver |
Version Model Number | OGFDR50K |
Company DUNS | 689051793 |
Company Name | Osstem Implant 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 | 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 | 08809917098702 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
[08809917098702]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-09 |
Device Publish Date | 2023-11-01 |
08809917098719 | OGFDR57K |
08809917098702 | OGFDR50K |
08809917098696 | OGFDM50K |
08809917098689 | OGFDM35K |
08800271234003 | HOGIDHSR57K |