FDA UDI
In Commercial Distribution
🇺🇸 United States
Kerecis® MariGen™
DI: 05694310962216
·
Model: Expanse 7x8 cm
·
KERECIS hf.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Kerecis® MariGen™
- Primary DI
- 05694310962216
- Version / Model
- Expanse 7x8 cm
- Catalog Number
- 50200N11B0D
- Company Name
- KERECIS hf.
- Labeler DUNS
- 365732410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-17
- Public Version
- 2
- Public Version Date
- 2023-10-05
- Public Version Status
- Update
- Public Device Record Key
- 9fd366da-fcd9-4094-91f3-654211481e4d
Device Description
Fish-skin graft for wound management. Kerecis® MariGen™ is indicated for the management of wounds including: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/
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
- 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 | 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 | 05694310962223 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 05694310962216 | GS1 | ||||
| Package | 05694310962254 | GS1 | Box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 7032878752
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132343 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7 | Centimeter | |
| Width | 8 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry