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
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00840117307643Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106902021-04-22
00840117307667Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106912021-04-22
00840117307681Ever-Soft Pommel Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106802021-04-22
00840117307704Ever-Soft Pommel Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106812021-04-22
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00616784065014Ever-Soft Foam Cushion 16" x 16" x 3"106502021-04-22
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00616784065212Ever-Soft Foam Cushion 18" x 18" x 3"106522021-04-22
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00616784065410Ever-Soft Foam Cushion 20" x 18" x 3"106542021-04-22
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00840117307582Ever-Soft Coccyx Foam Cushion 20" x 16" x 3"106562021-04-22
00840117326132Bariatric HD Patient Lift107072023-03-24
00616784067513Ever-Soft Alternating Pressure Air Cushion106752022-05-09
00616784042022DynaRest Multi-Zone Foam Mattress with Perimeter With Perimeter, 36" x 80" x 6"10420P2020-01-15
00616784070414Hydraulic Patient Lift107042019-09-30
00616784070018Electric Patient Lift107002019-09-25
00616784070117Bariatric Electric Patient Lift107012019-09-25

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