| Primary Device ID | 00815131023978 |
| NIH Device Record Key | a721c178-238c-41c5-9843-699973e4c2be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Sky Bio, LLC. |
| Version Model Number | AAH456515 |
| 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 | 00815131023978 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
[00815131023978]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-09-14 |