exsalt PT7 Contact Layer; 8" x 16"

Basic Information

• Brand Name: exsalt PT7 Contact Layer; 8" x 16"
• Primary DI: 07540127000406
• Version / Model: PN-09-0064
• Catalog Number: CL0816
• Company Name: Exciton Technologies Inc
• Labeler DUNS: 206405370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-18
• Public Version: 2
• Public Version Date: 2026-04-21
• Public Version Status: Update
• Public Device Record Key: ae177e7d-6b6e-4e37-af07-4fd257d3d7b4

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07540127000413	GS1	Box	10	In Commercial Distribution
Primary	07540127000406	GS1
Package	07540127000420	GS1	Case	4	In Commercial Distribution
Package	07540127000550	GS1	case	20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K182680	000

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	128	Square inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius