MicroMatrix® MMFX05

GUDID 00386190002056

MicroMatrix® Flex 5cc

ACELL, INC.

Collagen wound matrix dressing

• Primary Device ID: 00386190002056
• NIH Device Record Key: b97ff30c-3e68-45bf-a238-5b15de2ddd4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroMatrix®
• Version Model Number: MMFX05
• Catalog Number: MMFX05
• Company DUNS: 137258252
• Company Name: ACELL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.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

• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386190002056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230980

FDA Product Code

• KGN: Wound dressing with animal-derived material(s)

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: 2023-10-10
• Device Publish Date: 2023-10-02

On-Brand Devices [MicroMatrix®]

• 00386190001202: MicroMatrix, 1000 mg
• 00386190001196: MicroMatrix, 200 mg Fine Particulate
• 00386190001189: MicroMatrix, 500 mg
• 00386190001172: MicroMatrix, 200 mg
• 00386190001165: MicroMatrix, 100 mg Fine Particulate
• 00386190001158: MicroMatrix, 100 mg
• 00386190001141: MicroMatrix, 60 mg
• 00386190001134: MicroMatrix, 30 mg
• 00386190001127: MicroMatrix, 20 mg
• 00386190002056: MicroMatrix® Flex 5cc