FDA.report

Xeroform

Primary DI
20192253047841
Brand
Xeroform
Company
Cardinal Health 200, LLC
Model
8884433400
Catalog number
8884433400
Device description
Xeroform Occlusive Gauze Patch 3 percent Bismuth Tribromophenate in Petrolatum Blend 2 x 2 in. (5.1 x 5.1 cm)
Published
2025-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FRODressing, wound, drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20192253047841PackageGS125In Commercial Distribution
50192253047842PackageGS16In Commercial Distribution
10192253047844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019225304784120192253047841
5019225304784250192253047842
1019225304784410192253047844

GMDN Terms

TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Device Sizes

TypeValueUnit
Length5.1Centimeter
Width5.1Centimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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