FDA UDI
In Commercial Distribution
🇺🇸 United States
Exofin Fusion Skin Closure System SourceMark, 6cm
DI: 00854137001801
·
Model: M1266
·
CHEMENCE MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Exofin Fusion Skin Closure System SourceMark, 6cm
- Primary DI
- 00854137001801
- Version / Model
- M1266
- Catalog Number
- M1266
- Company Name
- CHEMENCE MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 079163089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-17
- Public Version
- 1
- Public Version Date
- 2022-05-25
- Public Version Status
- New
- Public Device Record Key
- fb51d6d8-d2e4-437c-ade2-0bf979f6f3d1
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| OMD | Cutaneous Tissue Adhesive With Mesh | General, Plastic Surgery | 878.4011 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46880 | Wound closure set, topical | A collection of sterile devices used to topically close easily-approximated skin edges of wounds. It typically includes a pressure-sensitive adhesive tape or mesh and a liquid adhesive, each contained within a dispensing applicator. The tape/mesh is first applied to temporarily approximate the skin edges followed by application of the liquid adhesive, over the tape/mesh, which polymerizes to affect wound closure. This set may be used to treat surgical incisions, simple lacerations, and may also be used in conjunction with deep dermal stitches. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10854137001808 | GS1 | Inner Pack | 6 | In Commercial Distribution | |
| Primary | 00854137001801 | GS1 |
Customer Contacts
- Phone
- 18446334583
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171442 | 000 |