| Primary Device ID | 00815131022230 |
| NIH Device Record Key | 38364a16-b69d-4189-9a93-590685d0a4df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Sky Bio, LLC. |
| Version Model Number | PG40FS2 |
| 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 | 00815131022230 [Primary] |
| GS1 | 10815131022237 [Package] Package: Carton [12 Units] In Commercial Distribution |
| GS1 | 20815131022234 [Package] Contains: 10815131022237 Package: Case [100 Units] In Commercial Distribution |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00815131022230]
Ethylene Oxide
[00815131022230]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-18 |
| Device Publish Date | 2015-10-23 |