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Theia Negative Pressure Wound Therapy Foam Dressing Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Theia Negative Pressure Wound Therapy Foam Dressing Kit FDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Model / Reference
- FWTL44 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850040200034 FDA UDI
- 510(k) Number
- K211277 FDA UDI
- FDA Product Code
- OMP FDA UDI
- GMDN Term
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Theia Negative Pressure Wound Therapy Foam Dressing Kit by Clear Choice Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
- ALIVIOVISCO — LIDERMED S.A. · Class I
- Gamgee BP – Non-sterile 45x45cm — Robinson Healthcare Ltd · Class I
- Herpatch — Sylphar nv · Class IIa
- N1 Psoriasis Intens Crème — PK Benelux BV · Class IIa
- Polyurethane Foam Dressing — Shandong Shinrise Medical Supplies Co., Ltd. · Class IIa
- Holland & Barrett Eczeem crème — PK Benelux BV · Class IIa
- Paraffin gauze dressings — Roosin Medical Co., Ltd. · Class IIa
- Innomed — Zhejiang Longterm Medical Technology Co., Ltd. · Class IIb
Cleared under the same submission
K211277 also covers:
- Theia Negative Pressure Wound Therapy Foam Dressing Kit — CLEAR CHOICE THERAPEUTICS, INC.
- Theia Negative Pressure Wound Therapy Foam Dressing Kit — CLEAR CHOICE THERAPEUTICS, INC.
- Theia Negative Pressure Wound Therapy Foam Dressing Kit — CLEAR CHOICE THERAPEUTICS, INC.
- Theia Negative Pressure Wound Therapy Foam Dressing Kit — CLEAR CHOICE THERAPEUTICS, INC.
- Theia Negative Pressure Wound Therapy Foam Dressing Kit — CLEAR CHOICE THERAPEUTICS, INC.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clear Choice Therapeutics, Inc.
Sources (1)
- FDA UDI b6e7ec17-dc6a-484b-a8cc-e52cbdc15a1e 33 fields · synced May 31, 2026