DEVICE: exsalt PT7 Contact Layer, 4" x 66" (07540127000529)
Device Identifier (DI) Information
exsalt PT7 Contact Layer, 4" x 66"
PN-09-0130
In Commercial Distribution
CL0466
Exciton Technologies Inc
PN-09-0130
In Commercial Distribution
CL0466
Exciton Technologies Inc
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.
Device Characteristics
MR Unsafe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
Yes | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47042 | Wound-nonadherent dressing, absorbent, antimicrobial |
A 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FRO | Dressing, Wound, Drug |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K182680 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Area/Surface Area: 1680 Square centimeter |
Device Record Status
2fecc6f4-2cd5-4aaa-982c-71555b2669ab
July 14, 2025
1
July 04, 2025
July 14, 2025
1
July 04, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
07540127000536 | 4 | 07540127000529 | In Commercial Distribution | Box | |
07540127000543 | 10 | 07540127000529 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
780-248-1281
mussyk@excitontech.com
mussyk@excitontech.com