A-Oss®A-graft®[Bone grafting material,Animal source]
GUDID 00814913025018
HIOSSEN, INC.
Dental bone matrix implant, animal-derived Dental bone matrix implant, animal-derived| Primary Device ID | 00814913025018 |
| NIH Device Record Key | 3e463a71-ecc0-44bb-a662-4c7bce270f77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A-Oss®A-graft®[Bone grafting material,Animal source] |
| Version Model Number | HAS200SV |
| Company DUNS | 796083090 |
| Company Name | HIOSSEN, INC. |
| 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 | true |
| 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 | 00814913025018 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151542
FDA Product Code
| NPM | Bone Grafting Material, Animal Source |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-10-03 |
| Device Publish Date | 2018-04-27 |
Devices Manufactured by HIOSSEN, INC.
Trademark Results [A-Oss]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A-OSS 79186040 5047552 Live/Registered |
OSSTEMIMPLANT CO., LTD. 2016-02-19 |
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