Identity
- Trade Name
- Dynamic Tissue Systems™ FDA UDI
- Generic Name
- Skin-closure adhesive strip FDA UDI
- Device Name
- DynaCleft Nasal Elevation System FDA UDI
- Model / Reference
- DCNE-01 FDA UDI
- Description
- DynaCleft Nasal Elevation System FDA UDI
Identifiers
- Catalog Number
- DCNE-01 FDA UDI
- Primary DI / UDI-DI
- 00620974001782 FDA UDI
- FDA Product Code
- MZR FDA UDI
- GMDN Term
- Skin-closure adhesive strip FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin-closure adhesive strip
Dynamic Tissue Systems™ by Southmedic Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin-closure adhesive strip.
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- 3M™ Steri-Strip™ — 3M COMPANY · Class I
- CareOne — Ahold U.S.A., Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
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
- Southmedic Incorporated
Sources (1)
- FDA UDI c8a2ba8b-6024-4684-a4ca-bb0ef65abb0a 35 fields · synced May 30, 2026