MicroMatrix® MM1000

GUDID 00386190001202

MicroMatrix, 1000 mg

ACELL, INC.

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 00386190001202
• NIH Device Record Key: f2d90a42-fee0-43e6-b46e-78e3b6d62037
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroMatrix®
• Version Model Number: MM1000
• Catalog Number: MM1000
• Company DUNS: 137258252
• Company Name: ACELL, 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: 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
• 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
• 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
• 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
• 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
• 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

• Weight: 1000 Milligram
• Weight: 1000 Milligram
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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
• 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
• 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
• 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
• 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
• 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	00386190001202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153754

FDA Product Code

• KGN: DRESSING, WOUND, COLLAGEN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-01-20

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