FDA.reportPublic FDA data

Durma+ Unna Boot Bandage with Zinc Oxide

Primary DI
00616784345413
Brand
Durma+ Unna Boot Bandage with Zinc Oxide
Company
Dynarex Corporation
Model
3454
Device description
"4"" x 10 yd (10.2 cm x 9.1m) "
Published
2025-12-17
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
00616784345437PackageGS112In Commercial Distribution
00616784345413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784345437006167843454376167843454370616784345437
00616784345413006167843454136167843454130616784345413

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.

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
00616784432120Cotton Tipped Plastic Applicators43212021-09-01
00616784432526Wooden Spoon, 3" (7.6 cm)43252026-04-27
00840117313347Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR362602022-05-17
00840117313385Resp-O2 Intubating Stylette, 6 Fr362652022-05-17
00840117313408Resp-O2 Intubating Stylette, 10 Fr362662022-05-17
00840117313422Resp-O2 Intubating Stylette, 12 Fr362672022-05-17
00840117315235Resp-O2 Intubating Stylette, 14 Fr362682022-05-17
00840117317451Resp-O2 Endotracheal Tube Cuffed, 4.0 mm362342024-10-24
00840117317468Resp-O2 Endotracheal Tube Cuffed, 4.5 mm362352024-10-24
00840117317482Resp-O2 Endotracheal Tube Cuffed, 5.5 mm362372024-10-24
00840117317499Resp-O2 Endotracheal Tube Cuffed, 6.0 mm362382024-10-24
00840117317505Resp-O2 Endotracheal Tube Cuffed, 6.5 mm362392024-10-24
00840117317512Resp-O2 Endotracheal Tube Cuffed, 7.0 mm362402024-10-24
00840117317529Resp-O2 Endotracheal Tube Cuffed, 7.5 mm362412024-10-24
00840117317536Resp-O2 Endotracheal Tube Cuffed, 8.0 mm362422024-10-24
00840117317543Resp-O2 Endotracheal Tube Cuffed, 8.5 mm362432024-10-24
00840117317550Resp-O2 Endotracheal Tube, Cuffed, 9.0 mm362442024-10-24
00840117318366Resp-O2 Durable Peak Flow Mouthpiece, With One-Way Valve, Adult361162021-04-22
00840117318373Resp-O2 Cardboard Peak Flow Mouthpiece, Disposable, Pediatric361172021-04-22
00840117318380Resp-O2 Cardboard Peak Flow Mouthpieces, Disposable, Adult361182021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16958868743069BiokerzonRoosin Medical Co., Ltd.NEC2026-04-27
08904428721399OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428721405OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745326OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745333OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
10885632460296HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460302HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460319HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460326HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460290HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
20885632460309HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460313HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460320HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10197344042098MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
10197344042111MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
20197344042095MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
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
20197344042101MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
20197344138903MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-15
00500223504328NOVIXSMITH & NEPHEW MEDICAL LIMITEDNEC2026-01-13
00500223504335NOVIXSMITH & NEPHEW MEDICAL LIMITEDNEC2026-01-13
00616784345512Durma+ Unna Boot Bandage with Zinc Oxide and Calamine Dynarex CorporationNEC2025-12-18
00616784345611Durma+ Unna Boot Bandage with Zinc Oxide and Calamine Dynarex CorporationNEC2025-12-18
00616784345314Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
00616784345437Durma+ Unna Boot Bandage with Zinc OxideDynarex CorporationNEC2025-12-17
05000223502706No Sting Skin PrepSMITH & NEPHEW MEDICAL LIMITEDNEC2025-11-26