FDA.reportPublic FDA data

AQUACEL AG ADVANTAGE

Primary DI
00768455145645
Brand
AQUACEL AG ADVANTAGE
Company
CONVATEC, PURCHASING DEPARTMENT
Model
422299
Catalog number
422299
Device description
Aquacel® Ag Advantage Enhanced Hydrofiber® Dressing With Silver 4X5" (10X12Cm)
Published
2022-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121275000AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERConvatec, Inc.2012-07-25FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00768455145645PackageGS110In Commercial Distribution
10768455145642PackageGS120In Commercial Distribution
00768455154371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455145645007684551456457684551456450768455145645
1076845514564210768455145642
00768455154371007684551543717684551543710768455154371

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, 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, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It 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 while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch
Length12Centimeter
Width5Inch
Width10Centimeter

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
00768455201303AVELLE4466504466502023-02-22
00768455108268STOMAHESIVE0255102022-09-28
00768455101399ACTIVELIFE0209222018-11-09
00768455101405ACTIVELIFE0227502018-11-09
00768455101412ACTIVELIFE0227512018-11-09
00768455101429ACTIVELIFE0227522018-11-09
00768455101436ACTIVELIFE0227532018-11-09
00768455101443ACTIVELIFE227542018-11-09
00768455101450ACTIVELIFE0227552018-11-09
00768455101467ACTIVELIFE0227562018-11-09
00768455101474ACTIVELIFE0227572018-11-09
00768455101481ACTIVELIFE0227582018-11-09
00768455101498ACTIVELIFE0227592018-11-09
00768455101504ACTIVELIFE0227602018-11-09
00768455101511ACTIVELIFE0227612018-11-09
00768455101528ACTIVELIFE0227622018-11-16
00768455101535ACTIVELIFE0227632018-11-16
00768455101542ACTIVELIFE0227642018-11-16
00768455101559ACTIVELIFE0227652018-11-16
00768455101566ACTIVELIFE0227662018-11-16

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