exsalt PT7 Contact Layer; 16" x 16" CL1616

GUDID 07540127000444

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.

Exciton Technologies Inc

Wound-nonadherent dressing, absorbent, antimicrobial

• Primary Device ID: 07540127000444
• NIH Device Record Key: c1b91424-4a83-4473-8e97-431d713d8223
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: exsalt PT7 Contact Layer; 16" x 16"
• Version Model Number: PN-09-0065
• Catalog Number: CL1616
• Company DUNS: 206405370
• Company Name: Exciton Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com
• Phone: 7802481281
• Email: mussyk@excitontech.com

Device Dimensions

• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch
• Area/Surface Area: 256 Square inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540127000437 [Primary]
GS1	07540127000444 [Package]; Contains: 07540127000437; Package: Box [5 Units]; In Commercial Distribution
GS1	07540127000451 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182680

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-26
• Device Publish Date: 2024-03-18

Devices Manufactured by Exciton Technologies Inc

• 07540127000352 - exsalt PT7 Contact Layer; 4" x 5": 2024-03-26 The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, ven
• 07540127000383 - exsalt PT7 Contact Layer, 6" x 6": 2024-03-26 The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, ven
• 07540127000413 - exsalt PT7 Contact Layer; 8" x 16": 2024-03-26 The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, ven
• 07540127000444 - exsalt PT7 Contact Layer; 16" x 16": 2024-03-26The 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.
• 07540127000444 - exsalt PT7 Contact Layer; 16" x 16": 2024-03-26 The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, ven
• 07540127000505 - exsalt PT7 Contact Layer; 16" x 32": 2024-03-26 The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, ven
• 07540127000468 - exsalt T7 Wound Dressing, 4" x 66": 2023-12-12 antimicrobial wound dressing, 4" x 66" in size
• 07540127000178 - exsalt CMC Gelling Fiber Dressing: 2023-07-18 exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium carboxymethylcellulose (CMC), ce
• 07540127000208 - exsalt CMC Gelling Fiber Dressing: 2023-07-18 exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium carboxymethylcellulose (CMC), ce