| Primary Device ID | 00810060221891 |
| NIH Device Record Key | 60ea5558-e642-49a2-bb1e-1ef20a5e7a06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Sky Bio, LLC. |
| Version Model Number | HJH4306 |
| Company DUNS | 618960848 |
| Company Name | BLUE SKY BIO LLC |
| 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 | false |
| Manufacturing Date | false |
| 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 | 00810060221891 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
[00810060221891]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-15 |
| Device Publish Date | 2021-07-07 |