FDA.reportPublic FDA data

exsalt CMC Gelling Fiber Dressing

Primary DI
07540127000291
Brand
exsalt CMC Gelling Fiber Dressing
Company
Exciton Technologies Inc
Model
PN-09-0125
Catalog number
GF0112
Device description
exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium 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, as shown in vitro, for up to seven (7) days against Gram-positive and Gram-negative bacteria. exsalt™ CMC Gelling Fiber Dressing absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately 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
OTC
false
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
07540127000291PackageGS15In Commercial Distribution
07540127000307PackageGS110In Commercial Distribution
07540127000284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540127000291075401270002917540127000291
07540127000307075401270003077540127000307
07540127000284075401270002847540127000284

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7802481281mussyk@excitontech.com

Regulatory Flags#

DUNS number
206405370
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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
true
Sterilization required before use
false

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
07540127000253exsalt CMC Gelling Fiber DressingPN-09-0124GF08122023-07-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428280669CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
00050428453599CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
50192253067901ASOCardinal Health 200, LLCFRO2026-06-03
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz TubeSion Brands LLCFRO2026-06-01
00714196111074DermaRite Medical DermaHoney Medical Grade Honey 1.75 oz TubeSion Brands LLCFRO2026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
00850087488266CeeportCEEPORT INC.FRO2026-05-29
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10