Microlyte Matrix

GUDID 00850019162028

Microlyte Matrix, 4" x 9" (10 cm x 23 cm), Box of 5

IMBED BIOSCIENCES, INC.

Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 00850019162028
• NIH Device Record Key: 86dd0984-9a39-4893-990e-92f38f1dc957
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microlyte Matrix
• Version Model Number: 91007
• Company DUNS: 962084500
• Company Name: IMBED BIOSCIENCES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com
• Phone: 888-472-9898
• Email: cs@imbedbio.com

Device Dimensions

• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter
• Area/Surface Area: 230 Square centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850019162028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153756

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: 2024-08-08
• Device Publish Date: 2024-07-31

On-Brand Devices [Microlyte Matrix]

• 00850019162240: Microlyte Matrix, 4 cm x 4 cm, Individually Packaged
• 00850019162233: Microlyte Matrix, 3 cm x 3 cm, Individually Packaged
• 00850019162042: Microlyte Matrix, 6" x 6" (15 cm x 15 cm), Box of 5
• 00850019162028: Microlyte Matrix, 4" x 9" (10 cm x 23 cm), Box of 5
• 00850019162004: MicroLyte Matrix, 2" x 9" (5cm x 23 cm), Box of 5