Identity
- Trade Name
- DIALFIX 15 FDA UDI
- Generic Name
- Skin-closing tension device FDA UDI
- Model / Reference
- 01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800125000037 FDA UDI
- FDA Product Code
- MKY FDA UDI
- GMDN Term
- Skin-closing tension device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Skin-closing tension device
Dialfix 15 by Dfix — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin-closing tension device.
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- HEMIGARD Interlock — SUTUREGARD MEDICAL, INC. · Class I
- DERMACLOSE — SYNOVIS MICRO COMPANIES ALLIANCE, INC · Class I
- MEGASORB — MERIL ENDO SURGERY PRIVATE LIMITED · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dfix
Sources (1)
- FDA UDI 3756f83c-c25e-444e-a49e-ead46d4b6387 34 fields · synced May 30, 2026