FDA UDI
In Commercial Distribution
🇺🇸 United States
FIBRACOL® PLUS
DI: 15051978001096
·
Model: 2982
·
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FIBRACOL® PLUS
- Primary DI
- 15051978001096
- Version / Model
- 2982
- Catalog Number
- 2982
- Company Name
- SYSTAGENIX WOUND MANAGEMENT, LIMITED
- Labeler DUNS
- 211352227
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-24
- Public Version
- 4
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- a19d3f53-7c4e-463a-a1f5-3c1a40218e02
Device Description
Collagen Wound Dressing with Alginate
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGN | Dressing, Wound, Collagen | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45023 | Animal-derived wound matrix dressing | A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25051978001093 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 15051978001096 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 10.2 | Centimeter | |
| Length | 11.1 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 30 Degrees Celsius