| Primary Device ID | 25051978003080 |
| NIH Device Record Key | 16a2d7da-5d9d-4a9d-a81f-fd19e55c45dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROMOGRAN® |
| Version Model Number | PG004 |
| Catalog Number | PG004 |
| Company DUNS | 211352227 |
| Company Name | SYSTAGENIX WOUND MANAGEMENT, LIMITED |
| 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 |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Area/Surface Area | 28 Square centimeter |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051978003083 [Primary] |
| GS1 | 25051978003080 [Package] Contains: 15051978003083 Package: [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 | 2019-10-02 |
| Device Publish Date | 2019-09-24 |
| 25051978003097 | Matrix Wound Dressing |
| 25051978003080 | Matrix Wound Dressing |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PROMOGRAN 76023540 2636375 Live/Registered |
KCI USA, INC. 2000-04-13 |