FDA.report

KALTOSTAT

Primary DI
00768455102259
Brand
KALTOSTAT
Company
CONVATEC, PURCHASING DEPARTMENT
Model
168210
Catalog number
168210
Device description
Kaltostat® Alginate Wound Dressing - 2" X 2"
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
00768455102259PackageGS110In Commercial Distribution
10768455102256PackageGS160In Commercial Distribution
00768455122783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455102259007684551022597684551022590768455102259
1076845510225610768455102256
00768455122783007684551227837684551227830768455122783

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
Length2Inch
Length5Centimeter
Width2Inch
Width5Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+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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