Xeroform Petrolatum Dressings

FDA UDI

Class U (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name: Xeroform Petrolatum Dressings FDA UDI
Generic Name: Wound hydrogel dressing, non-antimicrobial FDA UDI
Device Name: 3% Bismuth Tribromophenate in a petrolatum blend Med-High Absorbency For wound stages 2,3,4 FDA UDI
Model / Reference: 3042 FDA UDI
Description: 3% Bismuth Tribromophenate in a petrolatum blend Med-High Absorbency For wound stages 2,3,4 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840117324244 FDA UDI
510(k) Number: K152970 FDA UDI
FDA Product Code: FRO FDA UDI
GMDN Term: Wound hydrogel dressing, non-antimicrobial 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Wound hydrogel dressing, non-antimicrobial

Xeroform Petrolatum Dressings by Dynarex Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound hydrogel dressing, non-antimicrobial.

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HydroTac transparent 10x10cm steril P10 — Paul Hartmann Corp. · Class I
Hyalo4 Care Clear Hydrogel, 100g — Fidia Farmaceutici · U
CareOne — Ahold U.S.A., Inc. · Class I
NAR — NORTH AMERICAN RESCUE, LLC. · Class I
Simpurity — SAFE N SIMPLE LLC · Class I

Cleared under the same submission

K152970 also covers:

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: Dynarex Corp.

Sources (1)

FDA UDI ef85b13d-74d0-442e-82d2-7604f75709c4 34 fields · synced May 30, 2026