FDA.report

CARBOFLEX

Primary DI
00768455104284
Brand
CARBOFLEX
Company
CONVATEC, PURCHASING DEPARTMENT
Model
403202
Catalog number
403202
Device description
Carboflex® Odor Control Dressing - 4" X 4"
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
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00768455104284PackageGS110In Commercial Distribution
10768455104281PackageGS17In Commercial Distribution
00768455173099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455104284007684551042847684551042840768455104284
1076845510428110768455104281
00768455173099007684551730997684551730990768455173099

GMDN Terms

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

TypeValueUnit
Length4Inch
Length10Centimeter
Width4Inch
Width10Centimeter

Sterilization Methods

Method

Contacts

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

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