FDA.reportPublic FDA data

DUODERM PASTE AND GELS

Primary DI
00768455107063
Brand
DUODERM PASTE AND GELS
Company
CONVATEC, PURCHASING DEPARTMENT
Model
187987
Catalog number
187987
Device description
DuoDERM® Hydroactive® Gel - 30 Grams
Published
2022-09-05
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00768455107063PackageGS13In Commercial Distribution
10768455107060PackageGS160In Commercial Distribution
00768455172979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455107063007684551070637684551070630768455107063
1076845510706010768455107060
00768455172979007684551729797684551729790768455172979

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight30Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-422-8811cic@convatec.com
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
1
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10768455203946ESTEEM4236452024-09-13
10768455209481ESENTA4238272024-08-26
10768455209511ESENTA4238262024-08-26
00768455204793GENTLECATH5106002024-04-05
00768455204823GENTLECATH5106012024-04-05
00768455204854GENTLECATH5106022024-04-05
00768455207145GENTLECATH5106032024-04-05
00768455207169GENTLECATH5106042024-04-05
00768455207206GENTLECATH5106052024-04-05
10815947021172CURE PRODUCTSHM16UK2024-03-30
10768455203922ESTEEM4236432024-03-20
10768455203939ESTEEM4236442024-03-20
10768455203953ESTEEM4236462024-03-20
10768455203960ESTEEM4236472024-03-20
10768455203977ESTEEM4236482024-03-20
10768455204004ESTEEM4236512024-03-20
10768455204011ESTEEM4236522024-03-20
10768455204028ESTEEM4236532024-03-20
10768455204035ESTEEM4236542024-03-20
10768455204059ESTEEM4236562024-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975278040017delay sprayJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040024delay sprayJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040031delay cream/delay balm for menJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040048vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040055vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040062vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040079vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040086vaginal pleasure liquibead/climax intense liquibeadJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040116vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040123vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040130vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
00743537000449First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000715MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00860000562539LaviorLavior Pharma Inc.NAE2026-02-14
00860007877766LaviorLavior Pharma Inc.NAE2026-02-14
00860007877773LaviorLavior Pharma Inc.NAE2026-02-14
00860010195727LaviorLavior Pharma Inc.NAE2026-02-14
00860010195741LaviorLavior Pharma Inc.NAE2026-02-14
00850072068749CeladiaBiowound Solutions, Inc.NAE2025-12-18
06972864363031sknjxNingbo Chinmed Technology Co., Ltd.NAE2025-12-16
50192253040157KendallCardinal Health 200, LLCNAE2025-09-26
00197998326905Solventum™ Nu-Gel™Solventum US LLCNAE2025-09-22
00197998326981Solventum™ Nu-Gel™Solventum US LLCNAE2025-09-22
00858071004348Advanced Shield Hydrogel Silver Wound Barrier GEL, 2oz TubeKericure Inc.NAE2025-08-26
07290101428350Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDNAE2025-08-25
72901014283670Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDNAE2025-08-25
15056860000072Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000089Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
00858071004317Advanced Shield Chronic Wound Care, 2ozKericure Inc.NAE2025-08-08
00860000495097Altrazeal Transforming Powder DressingAltrazeal Life Sciences Inc.NAE2025-08-07