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Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.39
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.39 FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Drawtex Hydroconductive Wound Dressing with LevaFiber 18X0.39 (1 bx of 10 strips) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV). FDA UDI
- Model / Reference
- 00321 FDA UDI
- Description
- Drawtex Hydroconductive Wound Dressing with LevaFiber 18X0.39 (1 bx of 10 strips) is a nonmedicated dressing made up of natural and synthetic fibers: viscose, cotton and polyester. It is for the management of acute wounds, including complex surgical wounds and burns (first and second degree) and management of chronic wounds including leg ulcers, diabetic foot ulcers and pressure ulcers (stages II - IV). FDA UDI
Identifiers
- Catalog Number
- 00321 FDA UDI
- Primary DI / UDI-DI
- 00851383003214 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 0.39 Inch FDA UDIHeight — 18 Inch FDA UDI
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.39 by Urgo Medical North America, LLC — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Wound-nonadherent dressing, absorbent, non-antimicrobial.
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- Curity — Cardinalhealth · Class I
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- EMT - Class B Trauma - Bag — Certified Safety Manufacturing, 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
- Urgo Medical North America, LLC
Sources (1)
- FDA UDI e60032c5-17e2-462c-b777-ddf346035d4c 37 fields · synced Jun 9, 2026