FIBRACOL® PLUS 2981
GUDID 25051978001086
Collagen Wound Dressing with Alginate
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Collagen wound matrix dressing| Primary Device ID | 25051978001086 |
| NIH Device Record Key | 8aa82fe1-4b93-4e27-ad61-e2c80c8678d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIBRACOL® PLUS |
| Version Model Number | 2981 |
| Catalog Number | 2981 |
| 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
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
| Length | 5.1 Centimeter |
| Width | 5.1 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051978001089 [Primary] |
| GS1 | 25051978001086 [Package] Contains: 15051978001089 Package: [12 Units] In Commercial Distribution |
FDA Product Code
| KGN | Dressing, Wound, Collagen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2019-09-24 |
On-Brand Devices [FIBRACOL® PLUS]
| 25051978001116 | Collagen Wound Dressing with Alginate |
| 25051978001109 | Collagen Wound Dressing with Alginate |
| 25051978001093 | Collagen Wound Dressing with Alginate |
| 25051978001086 | Collagen Wound Dressing with Alginate |
Trademark Results [FIBRACOL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBRACOL 74516835 1946084 Live/Registered |
KCI USA, INC. 1994-04-25 |
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