FDA.reportPublic FDA data

Durma+ Unna Boot Bandage with Zinc Oxide and Calamine

Primary DI
00616784345512
Brand
Durma+ Unna Boot Bandage with Zinc Oxide and Calamine
Company
Dynarex Corporation
Model
3455
Device description
"Size: 3"" x 10 yd. (7.6 cm x 9.1m) "
Published
2025-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NECBandage, Liquid, Skin Protectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NECBandage, Liquid, Skin ProtectantGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784345536PackageGS112In Commercial Distribution
00616784345512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784345536006167843455366167843455360616784345536
00616784345512006167843455126167843455120616784345512

GMDN Terms#

Term, Definition table
TermDefinition
Skin-cover sealantA biodegradable, synthetic (e.g., cyanoacrylate) substance intended to be applied over a superficial wound to set and form a barrier to reduce skin exposure to external contaminants. Sometimes referred to as a liquid bandage, it is intended for use in the home or a clinical setting and may be intended as an alternative to a conventional skin-cover adhesive strip. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
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
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00840117331372LabChoice Flexible Inoculation Loops, Blue, Sterile, 10 ul431632025-03-21
00840117333567LabChoice Cell Lifters, Sterile, 18 cm431702025-06-16
00840117333581LabChoice Cell Scraper, Sterile, 25 cm431712025-06-16
00840117337374LabChoice Pet Cell Bottle, 500 mL431512025-06-16
00840117337381LabChoice Pet Cell Bottle, 1000 mL431522025-06-16
00840117341913Steel Button Folding Walker, Adult, With 5" Wheel, 32" - 39"10170-42026-08-03
00840117338067Resp-O2 M24 Oxygen E-Cylinder With CGA 870 Toggle Valve, 4.55 L36390-T2024-07-25
00840117338135Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve363942024-07-25
00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7L363922023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve363932023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve363912023-12-29
00840117326125Resp-O2 M24 Oxygen E-Cylinder, With CGA870 Post Valve363902023-03-24
00840117310162Resp-O2 Fingertip Pulse Oximeter, For Adult Use364002021-12-22
00840117341241Aluminum Crutches, Child, 4'0" - 4'6"10100-82026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"10101-82026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"10102-82026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"10103-82026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"10110-62026-07-31

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Primary DI, Brand, Company table
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08904428745333OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
10885632460296HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460302HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
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30885632460320HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
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10197344042111MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
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30197344042115MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
10197344042128MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-23
40197344042129MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-23
10197344042104MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
10197344138906MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
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20197344138903MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
00500223504328NOVIXSMITH & NEPHEW MEDICAL LIMITEDNEC2026-01-13
00500223504335NOVIXSMITH & NEPHEW MEDICAL LIMITEDNEC2026-01-13
00616784345611Durma+ Unna Boot Bandage with Zinc Oxide and Calamine Dynarex CorporationNEC2025-12-18
00616784345413Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
00616784345314Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
00616784345437Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
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