PROMOGRAN® PG019
GUDID 25051978003097
Matrix Wound Dressing
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Biochemically-interactive dressing| Primary Device ID | 25051978003097 |
| NIH Device Record Key | f5d7cff8-8ef7-49d3-8d03-5b893b2e4cdd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROMOGRAN® |
| Version Model Number | PG019 |
| Catalog Number | PG019 |
| 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 |
Device Dimensions
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
| Area/Surface Area | 123 Square centimeter |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051978003090 [Primary] |
| GS1 | 25051978003097 [Package] Contains: 15051978003090 Package: [10 Units] In Commercial Distribution |
FDA Product Code
| FRO | Dressing, Wound, Drug |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-02 |
| Device Publish Date | 2019-09-24 |
On-Brand Devices [PROMOGRAN®]
| 25051978003097 | Matrix Wound Dressing |
| 25051978003080 | Matrix Wound Dressing |
Trademark Results [PROMOGRAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROMOGRAN 76023540 2636375 Live/Registered |
KCI USA, INC. 2000-04-13 |
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