FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ColActive® Plus Powder
DI: 00825439017241
·
Model: 80P0001
·
Covalon Technologies Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ColActive® Plus Powder
- Primary DI
- 00825439017241
- Version / Model
- 80P0001
- Company Name
- Covalon Technologies Ltd
- Labeler DUNS
- 206936101
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 4
- Public Version Date
- 2023-11-30
- Public Version Status
- Update
- Public Device Record Key
- 3335439d-a8ea-40d0-87ac-38814ff986a8
- Distribution End Date
- 2023-11-30
Device Description
Collagen dressing
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
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45023 | Collagen wound matrix dressing | A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00825439017258 | GS1 | Carton | 10 | Not in Commercial Distribution | 2023-11-30 |
| Primary | 00825439017241 | GS1 | ||||
| Package | 10825439017255 | GS1 | Shipper | 10 | Not in Commercial Distribution | 2023-11-30 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060804 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius