Durma+ Unna Boot Bandage with Zinc Oxide and Calamine

GUDID 00616784345611

Size: 4" x 10 yd. (10.2 cm x 9.1m)

Dynarex Corporation

Skin-cover sealant
Primary Device ID00616784345611
NIH Device Record Key4450f659-0b68-4361-8f73-165b82a8860f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDurma+ Unna Boot Bandage with Zinc Oxide and Calamine
Version Model Number3456
Company DUNS008124539
Company NameDynarex Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784345611 [Primary]
GS100616784345635 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

NECBandage, Liquid, Skin Protectant

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-26
Device Publish Date2025-12-18

On-Brand Devices [Durma+ Unna Boot Bandage with Zinc Oxide and Calamine ]

00616784345611Size: 4" x 10 yd. (10.2 cm x 9.1m)
00616784345512Size: 3" x 10 yd. (7.6 cm x 9.1m)

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