Identity
- Trade Name
- exsalt PT7 Contact Layer; 16" x 16" FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- PN-09-0065 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- CL1616 FDA UDI
- Primary DI / UDI-DI
- 07540127000437 FDA UDI
- 510(k) Number
- K182680 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
- Models / Variants
- exsalt PT7 Contact Layer FDA UDI16" x 16" 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 256 Square inch FDA UDI
Category: Wound-nonadherent dressing, absorbent, antimicrobial
exsalt PT7 Contact Layer +1 more model by Exciton Technologies Inc — Class U — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as Wound-nonadherent dressing, absorbent, antimicrobial.
- Suprasorb P Sensitive Ag — L&R USA INC. · U
- Silverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLC · U
- DeRoyal — DEROYAL INDUSTRIES, INC. · U
- ACTICOAT SURGIC 10X12CM 5PK US — Smith & Nephew Medical, Ltd. · U
- ALLEVYN AG ADHESIVE 7X7" CTN10 — Smith & Nephew Medical, Ltd. · U
- URGOCELL AG/SILVER — LABORATOIRES URGO · U
- Kendall — Cardinalhealth · U
- Exchange Select — Aafes · U
Cleared under the same submission
K182680 also covers:
- exsalt PT7 Contact Layer, 4" x 66" — Exciton Technologies Inc
- exsalt PT7 Contact Layer, 6" x 6" — Exciton Technologies Inc
- exsalt PT7 Contact Layer; 16" x 32" — Exciton Technologies Inc
- exsalt PT7 Contact Layer; 4" x 5" — Exciton Technologies Inc
- exsalt PT7 Contact Layer; 8" x 16" — Exciton Technologies Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exciton Technologies Inc
Sources (1)
- FDA UDI c1b91424-4a83-4473-8e97-431d713d8223 38 fields · synced Jun 8, 2026