Primary Device ID | 08800000925431 |
NIH Device Record Key | 2d33930f-4bb4-462f-a6b8-0678b581dba8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hiossen Prosthetic System |
Version Model Number | ORN1R |
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 | 08800000925431 [Primary] |
NHA | Abutment, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800000925431]
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 | 2015-10-16 |
08800000963327 | OAON01S |
08800000925608 | ETHLAP5M |
08800000925592 | ETHLAP7M |
08800000925585 | ETHLAP9M |
08800000925578 | ETHLAP5R |
08800000925561 | ETHLAP7R |
08800000925554 | ETHLAP9R |
08800000925547 | GSCHABSMT |
08800000925530 | GSCHABSST |
08800000925523 | HGNCA401MHW |
08800000925516 | HGNCA403MHW |
08800000925509 | HGNCA401MNW |
08800000925493 | HGNCA403MNW |
08800000925486 | HGNCA451SHW |
08800000925479 | HGNCA453SHW |
08800000925462 | HGNCA451SNW |
08800000925455 | HGNCA453SNW |
08800000925448 | ORN1C |
08800000925431 | ORN1R |
08800000925424 | ORN1 |
08800000925417 | MGR100TH |
08800000925400 | MGW100TH |
08800000925394 | MGR200TH |
08800000925387 | MGW200TH |
08809892359041 | MGW200TH |
08809892359027 | MGW100TH |
08809892359003 | MGR200TH |
08809892358983 | MGR100TH |