| Primary Device ID | 00810060225141 |
| NIH Device Record Key | de9fdea9-d0db-4594-b203-ccae0a7e2554 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Sky Bio, LLC. |
| Version Model Number | IHGSC |
| Company DUNS | 618960848 |
| Company Name | BLUE SKY BIO LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | 00810060225141 [Primary] |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
[00810060225141]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-10 |
| Device Publish Date | 2022-11-02 |