| Primary Device ID | 00815131029628 |
| NIH Device Record Key | f8613f85-9468-454d-9237-b5e5b4f95dba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Sky Bio, LLC. |
| Version Model Number | DRILLD22L |
| 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 | 00815131029628 [Primary] |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
[00815131029628]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-14 |
| Device Publish Date | 2020-08-06 |