FDA.reportPublic FDA data

"Xeroform Petrolatum Dressings, 4""x4"""

Primary DI
00616784305318
Brand
"Xeroform Petrolatum Dressings, 4""x4"""
Company
Dynarex Corporation
Model
3053
Device description
3% Bismuth Tribromophenate in a petrolatum blend, Sterile
Published
2022-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152970000Dynarex Xeroform Petrolatum DressingDynarex Corporation2016-10-03FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784305325PackageGS125In Commercial Distribution
00616784305332PackageGS14In Commercial Distribution
00616784305318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784305325006167843053256167843053250616784305325
00616784305332006167843053326167843053320616784305332
00616784305318006167843053186167843053180616784305318

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117308558Resp-O2 Aerosol Standard Adult Mask340002021-04-22
00840117308572Resp-O2 Aerosol Elongated Masks, Adult340032021-04-22
00840117308619Resp-O2 Small Volume Nebulizer 6 cc Cup341042021-04-22
00840117308633Resp-O2 Small Volume Nebulizer 6cc Cup341052021-04-22
00840117308657Resp-O2 Small Volume Nebulizer 6 cc Cup341202021-04-22
00840117311732Resp-O2 Aerosol Standard Mask, Pediatric340012021-04-22
00840117311770Resp-O2 Aerosol Elongated Masks, Pediatric340042021-04-22
00840117311794Resp-O2 Aerosol Face Tent Mask, Adult340052021-04-22
00840117311817Resp-O2 Small Volume Nebulizer341002021-04-22
00840117311831Resp-O2 Small Volume Nebulizer 6 cc Cup341012021-04-22
00840117311855Resp-O2 Small Volume Nebulizer 6 cc Cup341022021-04-22
00840117311879Resp-O2 Small Volume Nebulizer 6 cc Cup341032021-04-22
00840117311893Resp-O2 Small Volume Nebulizer 6 cc Cup341062021-04-22
00840117311916Resp-O2 Small Volume Pacifier Nebulizer Kit341072021-04-22
00840117318007Resp-O2 Tracheostomy Adult Mask340212021-04-22
00840117318014Resp-O2 Tracheostomy Pediatric Mask340222021-04-22
00840117318069Resp-O2 Tracheostomy Adult Mask340202021-04-22
00840117311756Resp-O2 Aerosol Standard Mask, Infant340022021-01-19
00840117311534Resp-O2 Oxygen Supply Tubing332002021-04-22
00840117311558Resp-O2 Oxygen Supply Tubing332012021-04-22

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Primary DI, Brand, Company table
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00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
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10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
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00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
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