FDA.reportPublic FDA data

AQUACEL AG SURGICAL

Primary DI
00768455130788
Brand
AQUACEL AG SURGICAL
Company
CONVATEC, PURCHASING DEPARTMENT
Model
413554
Device description
AQUACEL AG SURGICAL SP 9X30CM (1X10)NAI
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYXTUBING, PRESSURE AND ACCESSORIES
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152926000AQUACEL Ag Surgical SP DressingConvatec Limited2016-01-21FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00768455130696PackageGS110In Commercial Distribution
10768455130693PackageGS120In Commercial Distribution
00768455130788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455130696007684551306967684551306960768455130696
1076845513069310768455130693
00768455130788007684551307887684551307880768455130788

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, antimicrobial, sterileA sterile wound covering, typically made of a hydrocolloid, hydrofibre, 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
Length9Centimeter
Length30Centimeter
Width9Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768455145836FLEXI-SEAL4217032019-11-18
00768455157150FLEXI-SEAL4223032019-11-18
00768455185924FLEXI-SEAL4111082022-09-09
00768455209620FLEXI-SEAL4238542023-08-16
30768455143017FLEXI-SEAL4216304216302017-04-26
00768455108565FLEXI-SEAL4111004111002016-09-01
00768455109852FLEXI-SEAL4111004111002016-09-01
00768455117178FLEXI-SEAL4180002016-09-01
00768455143016FLEXI-SEAL4216302017-05-12
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

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