FDA.report

DuDress®

Primary DI
00809958089217
Brand
DuDress®
Company
Derma Sciences Canada Inc
Model
89166
Catalog number
DUP89166
Device description
6 in X 6 in Composite barrier dressing. Sterile
Published
2018-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NADDressing, wound, occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00809958089217PrimaryGS10
00809958089200Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00809958089217008099580892178099580892170809958089217
00809958089200008099580892008099580892000809958089200

GMDN Terms

TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
200564891
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00809958188002ALGICELL® Ag88545DUP885452025-01-08
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30381780491716PETROLATUM GAUZE®20053DKC200532018-10-23
30381780491723PETROLATUM GAUZE®20056DKC200562018-10-23
30381780491730PETROLATUM GAUZE®20059DKC200592018-10-23
30381780491747PETROLATUM GAUZE®20062DKC200622018-10-23
30381780491754PETROLATUM GAUZE®20065DKC200652018-10-23
30381780491761PETROLATUM GAUZE®77030DKC770302018-10-23
30381780491853PrimaDerm®69101DUP691012018-10-23
30381780491884Pak-its®59145DUP591452018-10-23
30381780491891Pak-its®59146DUP591462018-10-23
30381780491907Pak-its®59245DUP592452018-10-23
30381780491914Pak-its®59246DUP592462018-10-23
30381780491921Pak-its®59345DUP593452018-10-23
30381780491938Pak-its®59346DUP593462018-10-23

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20885632495882HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
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