FDA.reportPublic FDA data

exsalt PT7 Contact Layer; 16" x 32"

Primary DI
07540127000505
Brand
exsalt PT7 Contact Layer; 16" x 32"
Company
Exciton Technologies Inc
Model
PN-09-0066
Catalog number
CL1632
Device description
The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and graft wounds. The exsalt™ PT7 Contact Layer maintains its antibacterial activity for up to seven days as shown in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii. Silver in the exsalt™ PT7 Contact Layer inhibits bacterial growth in the dressing.
Published
2024-03-18
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
K182680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182680000KerraContact Ag Perf Advanced Perforated Silver Wound DressingExciton Technologies, Inc.2018-12-06FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540127000505PackageGS15In Commercial Distribution
07540127000512PackageGS110In Commercial Distribution
07540127000499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540127000505075401270005057540127000505
07540127000512075401270005127540127000512
07540127000499075401270004997540127000499

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area512Square inch

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
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
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