FDA UDI
In Commercial Distribution
🇺🇸 United States
Kerecis® SurgiBind™
DI: 05694310961899
·
Model: 300 sq cm
·
KERECIS hf.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Kerecis® SurgiBind™
- Primary DI
- 05694310961899
- Version / Model
- 300 sq cm
- Catalog Number
- 50241S23D0D
- Company Name
- KERECIS hf.
- Labeler DUNS
- 365732410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-11
- Public Version
- 5
- Public Version Date
- 2023-10-06
- Public Version Status
- Update
- Public Device Record Key
- 119762d8-3ba4-4669-ae28-e62e0c44d04f
Device Description
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
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
- MR Safe
- 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 |
|---|---|---|---|---|
| OXH | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60907 | Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial | A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05694310961905 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 05694310961899 | GS1 |
Customer Contacts
- Phone
- 7032878752
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202430 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 300 | Square 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