FDA UDI
In Commercial Distribution
🇺🇸 United States
Kerecis® GraftGuide®
DI: 05694310965361
·
Model: 300 sq cm Meshed 3:1
·
KERECIS hf.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Kerecis® GraftGuide®
- Primary DI
- 05694310965361
- Version / Model
- 300 sq cm Meshed 3:1
- Catalog Number
- 50202O23D0D
- Company Name
- KERECIS hf.
- Labeler DUNS
- 365732410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-29
- Public Version
- 1
- Public Version Date
- 2025-09-08
- Public Version Status
- New
- Public Device Record Key
- d66344a6-fb3a-4441-b293-a84b9c78577b
Device Description
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/
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 | Wound Dressing With Animal-Derived Material(S) | 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 | 05694310965378 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 05694310965361 | GS1 |
Customer Contacts
- Phone
- 7032878752
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190528 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 300 | Square centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 25 Degrees Celsius
- Type
- Handling 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