| Primary Device ID | 00854827008660 |
| NIH Device Record Key | b23b8119-4f96-48c8-9038-dfef0999c7f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydrofera Blue Ready Border |
| Version Model Number | HBRB5959E |
| Company DUNS | 080660602 |
| Company Name | HYDROFERA, 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 5.9 Inch |
| Width | 5.9 Inch |
| Length | 5.9 Inch |
| Width | 5.9 Inch |
| Length | 5.9 Inch |
| Width | 5.9 Inch |
| Length | 5.9 Inch |
| Width | 5.9 Inch |
| Length | 5.9 Inch |
| Width | 5.9 Inch |
| Length | 5.9 Inch |
| Width | 5.9 Inch |
| Length | 5.9 Inch |
| Width | 5.9 Inch |
| Length | 5.9 Inch |
| Width | 5.9 Inch |
| Length | 5.9 Inch |
| Width | 5.9 Inch |
| Length | 5.9 Inch |
| Width | 5.9 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854827008653 [Primary] |
| GS1 | 00854827008660 [Package] Contains: 00854827008653 Package: Box [10 Units] In Commercial Distribution |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-02 |
| Device Publish Date | 2024-11-22 |
| 00854827008684 | Hydrofera Blue Ready Border 6"x8" |
| 00854827008660 | Hydrofera Blue Ready Border 5.9"x5.9" |
| 00854827008646 | Hydrofera Blue Ready Border 4"x4" |