BasaDrox Rx Wound Gel

FDA UDI

Class U (US FDA UDI)

by Alvix Laboratories, Llc

Identity

Trade Name: BasaDrox Rx Wound Gel FDA UDI
Generic Name: Wound hydrogel dressing, non-sterile FDA UDI
Device Name: BasaDrox Rx Wound Gel is a wound dressing hydrogel that helps maintain a moist wound environment that is conducive to healing by either absorbing or donating moisture and wound exudates. FDA UDI
Model / Reference: FP1019-20 FDA UDI
Description: BasaDrox Rx Wound Gel is a wound dressing hydrogel that helps maintain a moist wound environment that is conducive to healing by either absorbing or donating moisture and wound exudates. FDA UDI

Identifiers

Primary DI / UDI-DI: 00315455956834 FDA UDI
510(k) Number: K162017 FDA UDI
FDA Product Code: FRO FDA UDI
GMDN Term: Wound hydrogel dressing, non-sterile FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Wound hydrogel dressing, non-sterile

BasaDrox Rx Wound Gel by Alvix Laboratories, Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K162017 also covers:

AzaDrox Rx Wound Gel — ALVIX LABORATORIES, LLC

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: Alvix Laboratories, Llc

Sources (1)

FDA UDI dbc373b6-a258-4261-b3db-9da8d782dbc8 35 fields · synced May 30, 2026