| Primary Device ID | 20815131027581 |
| NIH Device Record Key | 69962a0f-b5d2-49b1-a76d-baea0ab71e8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Sky Bio, LLC. |
| Version Model Number | PGF40FS2 |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00815131027587 [Primary] |
| GS1 | 10815131027584 [Package] Contains: 00815131027587 Package: Carton [12 Units] In Commercial Distribution |
| GS1 | 20815131027581 [Package] Contains: 10815131027584 Package: Case [100 Units] In Commercial Distribution |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-13 |
| Device Publish Date | 2019-12-05 |