FDA.reportPublic FDA data

Solventum™ Kerracel™

Primary DI
00197998295812
Brand
Solventum™ Kerracel™
Company
Solventum US LLC
Model
CWL1033
Catalog number
CWL1033
Device description
Solventum™ Kerracel™ Gelling Fiber Dressing, CWL1033, 4 in x 5 in (10 cmx 12.5 cm), 10/CAR, 10 CAR/CS, 100/CS
Published
2026-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00197998295829PackageGS110In Commercial Distribution
00197998295812PrimaryGS10
00197998295805Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998295829001979982958291979982958290197998295829
00197998295812001979982958121979982958120197998295812
00197998295805001979982958051979982958050197998295805

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
119004140
Device count
10
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
true
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
00197998095641Transpore™1527-01527-02026-09-25
00197998095672Transpore™1527-11527-12026-09-25
00197998095702Transpore™1527-21527-22026-09-25
00197998095733Transpore™1527-31527-32026-09-25
00197998095788Transpore™1527S-11527S-12026-09-25
00197998103612Transpore™1534-1241534-1242026-09-25
00197998103636Transpore™1534S-21534S-22026-09-25
00197998164118Transpore™1527S-21527S-22026-09-25
00197998302718Solventum™21174211742026-09-25
00197998001246Solventum™ Tegaderm™1877-21001877-21002026-08-23
00197998001277Solventum™ Tegaderm™1879-21001879-21002026-08-23
00197998001369Solventum™ Tegaderm™166416642026-08-23
00197998002861Solventum™ Tegaderm™9132NS9132NS2026-08-23
00197998149016Solventum™ Tegaderm™358435842026-08-23
00197998149047Solventum™ Tegaderm™358235822026-08-23
00197998149078Solventum™ Tegaderm™358735872026-08-23
00197998149382Solventum™ Tegaderm™358635862026-08-23
00197998149412Solventum™ Tegaderm™359335932026-08-23
00197998149443Solventum™ Tegaderm™359035902026-08-23
00197998149474Solventum™ Tegaderm™358835882026-08-23

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Primary DI, Brand, Company table
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04260223630262curea P1curea medical GmbHNAC2026-09-27
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04260223630286curea P1 draincurea medical GmbHNAC2026-09-27
04260223630347curea P2curea medical GmbHNAC2026-09-27
04260223630378curea P2curea medical GmbHNAC2026-09-27
04260223630408curea P2curea medical GmbHNAC2026-09-27
04260223630422curea P2curea medical GmbHNAC2026-09-27
04260223630651curea P1curea medical GmbHNAC2026-09-27
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04260223630736curea P1curea medical GmbHNAC2026-09-27
04260223630880curea P1curea medical GmbHNAC2026-09-27
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04260223631757curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631771curea P2 activecurea medical GmbHNAC2026-09-27
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04260223631849curea P2 activecurea medical GmbHNAC2026-09-27
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00749756401920DeRoyalDEROYAL INDUSTRIES, INC.NAC2026-09-18
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