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exsalt PT7 Contact Layer, 4" x 66"

FDA UDI

Class U (US FDA UDI)

by Exciton Technologies Inc

Identity

Trade Name
exsalt PT7 Contact Layer, 4" x 66" FDA UDI
Generic Name
Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
Device Name
The exsalt PT7 Contact Layer contains silver that inhibits bacterial growth in the dressing, as shown in-vitro for up to 7 days against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumanii. The exsalt PT7 Contact Layer consists of three layers: Two non adherent polyethylene mesh wound contact layers and an absorbent core made of polyester; all three layers are silver coated. The concentration of silver on the exsalt PT7 Contact Layer is approximately 0.4 mg/cm2 (4.5% w/w). The exsalt PT7 Contact layer meets pyrogen limit specifications. The exsalt PT7 Contact Layer is indicated for use in 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 grafted wounds. FDA UDI
Model / Reference
PN-09-0130 FDA UDI
Description
The exsalt PT7 Contact Layer contains silver that inhibits bacterial growth in the dressing, as shown in-vitro for up to 7 days against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumanii. The exsalt PT7 Contact Layer consists of three layers: Two non adherent polyethylene mesh wound contact layers and an absorbent core made of polyester; all three layers are silver coated. The concentration of silver on the exsalt PT7 Contact Layer is approximately 0.4 mg/cm2 (4.5% w/w). The exsalt PT7 Contact layer meets pyrogen limit specifications. The exsalt PT7 Contact Layer is indicated for use in 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 grafted wounds. FDA UDI

Identifiers

Catalog Number
CL0466 FDA UDI
Primary DI / UDI-DI
07540127000529 FDA UDI
510(k) Number
K182680 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Area/Surface Area — 1680 Square centimeter FDA UDI

Category: Wound-nonadherent dressing, absorbent, antimicrobial

exsalt PT7 Contact Layer, 4" x 66" by Exciton Technologies Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound-nonadherent dressing, absorbent, antimicrobial.

Cleared under the same submission

K182680 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exciton Technologies Inc

Sources (1)

  • FDA UDI 2fecc6f4-2cd5-4aaa-982c-71555b2669ab 38 fields · synced May 30, 2026