FDA.reportPublic FDA data

exsalt CMC Gelling Fiber Dressing

Primary DI
07540127000253
Brand
exsalt CMC Gelling Fiber Dressing
Company
Exciton Technologies Inc
Model
PN-09-0124
Catalog number
GF0812
Device description
exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made ofsodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/cm2) (1.7wt/wt%).The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, asshown in vitro, for up to seven (7) days against Gram-positive and Gram-negative bacteria. exsalt™ CMCGelling Fiber Dressing absorbs high amounts of wound fluid and creates a soft cohesive gel thatintimately conforms to the wound surface and maintains a moist wound healing environment.
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162508000KerraCel Ag Gelling Fiber Silver DressingExciton Technologies, Inc.2017-02-13FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540127000260PackageGS15In Commercial Distribution
07540127000277PackageGS110In Commercial Distribution
07540127000253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540127000260075401270002607540127000260
07540127000277075401270002777540127000277
07540127000253075401270002537540127000253

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, 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, 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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
7802481281mussyk@excitontech.com

Regulatory Flags#

DUNS number
206405370
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540127000406exsalt PT7 Contact Layer; 8" x 16"PN-09-0064CL08162024-03-18
07540127000437"exsalt PT7 Contact Layer; 16"" x 16"""PN-09-0065CL16162024-03-18
07540127000468"exsalt T7 Wound Dressing, 4"" x 66"""BM-09-0166T704662023-12-04
07540127000529"exsalt PT7 Contact Layer, 4"" x 66"""PN-09-0130CL04662025-07-04
07540127000345"exsalt PT7 Contact Layer; 4"" x 5"""PN-09-0062CL04052024-03-18
07540127000376"exsalt PT7 Contact Layer, 6"" x 6"""PN-09-0063CL06062024-03-18
07540127000499"exsalt PT7 Contact Layer; 16"" x 32"""PN-09-0066CL16322024-03-18
07540127000352exsalt PT7 Contact Layer; 4" x 5"PN-09-0062CL04052024-03-18
07540127000383exsalt PT7 Contact Layer, 6" x 6"PN-09-0063CL06062024-03-18
07540127000413exsalt PT7 Contact Layer; 8" x 16"PN-09-0064CL08162024-03-18
07540127000444exsalt PT7 Contact Layer; 16" x 16"PN-09-0065CL16162024-03-18
07540127000505exsalt PT7 Contact Layer; 16" x 32"PN-09-0066CL16322024-03-18
07540127000161exsalt CMC Gelling Fiber DressingPN-09-0121GF02022023-07-10
07540127000192exsalt CMC Gelling Fiber DressingPN-09-0122GF04052023-07-10
07540127000222exsalt CMC Gelling Fiber DressingPN-09-0123GF06062023-07-10
07540127000284exsalt CMC Gelling Fiber DressingPN-09-0125GF01122023-07-10
07540127000314exsalt CMC Gelling Fiber DressingPN-09-0126GF01182023-07-10
07540127000178exsalt CMC Gelling Fiber DressingPN-09-0121GF02022023-07-10
07540127000208exsalt CMC Gelling Fiber DressingPN-09-0122GF04052023-07-10
07540127000239exsalt CMC Gelling Fiber DressingPN-09-0123GF06062023-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
05000223503697ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
00197998001369Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998002861Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173523Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998173554Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998432415Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
00050428034873CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
00050428034880CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-08-08
10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28