Identity
- Trade Name
- SurgiClear 6x25 FDA UDI
- Generic Name
- Antimicrobial synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- Antimicrobial clear silicone adhesive dressing FDA UDI
- Model / Reference
- TWBD1024 FDA UDI
- Description
- Antimicrobial clear silicone adhesive dressing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00825439010433 FDA UDI
- 510(k) Number
- K121819 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Antimicrobial synthetic polymer semi-permeable film dressing, adhesive FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 25 Centimeter FDA UDIWidth — 6 Centimeter FDA UDI
Category: Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
SurgiClear 6x25 by Covalontechnologies, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 U | Pending data |
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Manufacturer
- Manufacturer
- Covalontechnologies, Inc.
Sources (1)
- FDA UDI f5eacc39-b61a-4ca6-b3e8-16e295796679 36 fields · synced May 30, 2026