Primary Device ID | 08809324764344 |
NIH Device Record Key | 3f683545-132f-4853-b7b9-3609a9fd26ee |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OSTEON II |
Version Model Number | DT7G1020100 |
Catalog Number | DT7G1020100 |
Company DUNS | 690083006 |
Company Name | GENOSS CO., Ltd. |
Device Count | 1 |
DM Exempt | true |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Total Volume | 1 Milliliter |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08809324764344 [Primary] |
LYC | Bone grafting material, synthetic |
Steralize Prior To Use | true |
Device Is Sterile | true |
[08809324764344]
Radiation Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2016-03-09 |
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