FDA.reportPublic FDA data

KALTOSTAT

Primary DI
00768455122776
Brand
KALTOSTAT
Company
CONVATEC, PURCHASING DEPARTMENT
Model
168117
Device description
Kaltostat® Alginate Rope - 2 Gm.
Published
2022-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00768455102242PackageGS15In Commercial Distribution
10768455102249PackageGS130In Commercial Distribution
00768455122776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455102242007684551022427684551022420768455102242
1076845510224910768455102249
00768455122776007684551227767684551227760768455122776

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
Weight2Gram

Contacts#

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

Regulatory Flags#

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

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
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09551031940076DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
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09551031940212DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940229DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22