Microlyte Matrix

GUDID 00850019162219

Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of bioresorbable polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.

IMBED BIOSCIENCES, INC

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

• Primary Device ID: 00850019162219
• NIH Device Record Key: 33d7c37b-f845-4c96-b08a-14304d99d4b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microlyte Matrix
• Version Model Number: ML0202
• 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: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com
• Phone: 888-472-9898
• Email: support@imbedbio.com

Device Dimensions

• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 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
• 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
• 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
• 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	00850019162219 [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: 2023-02-10
• Device Publish Date: 2023-02-02

On-Brand Devices [Microlyte Matrix]

• 00860001725735: Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
• 00860001725711: Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
• 00850019162226: Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
• 00850019162219: Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
• 00850019162172: Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
• 00850019162165: Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
• 00850019162158: Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
• 00850019162110: Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily
• 00850019162103: Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily