exsalt CMC Gelling Fiber Dressing GF0812

GUDID 07540127000260

exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/cm2) (1.7wt/wt%). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against Gram-positive and Gram-negative bacteria. exsalt™ CMC Gelling Fiber Dressing absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment.

Exciton Technologies Inc

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• Primary Device ID: 07540127000260
• NIH Device Record Key: 1a9b5aee-8185-4af8-a6ff-4c585e283de8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: exsalt CMC Gelling Fiber Dressing
• Version Model Number: PN-09-0124
• Catalog Number: GF0812
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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	07540127000253 [Primary]
GS1	07540127000260 [Package]; Contains: 07540127000253; Package: box [5 Units]; In Commercial Distribution
GS1	07540127000277 [Package]; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162508

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: 2023-07-18
• Device Publish Date: 2023-07-10

On-Brand Devices [exsalt CMC Gelling Fiber Dressing]

• 07540127000321: exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium
• 07540127000291: exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium
• 07540127000260: exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium
• 07540127000239: exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium
• 07540127000208: exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium
• 07540127000178: exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium