MatriStem MM0020

GUDID 00386190000007

MicroMatrix, 20 mg

ACELL, INC.

Collagen wound matrix dressing

• Primary Device ID: 00386190000007
• NIH Device Record Key: 292d8361-dad3-489f-84e9-3566cfbc986c
• Commercial Distribution Discontinuation: 2018-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MatriStem
• Version Model Number: MM0020
• Catalog Number: MM0020
• 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

Device Dimensions

• Weight: 20 Milligram
• Weight: 20 Milligram
• Weight: 20 Milligram
• Weight: 20 Milligram
• Weight: 20 Milligram
• Weight: 20 Milligram
• Weight: 20 Milligram
• Weight: 20 Milligram
• Weight: 20 Milligram
• Weight: 20 Milligram
• Weight: 20 Milligram

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386190000007 [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: 6
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-01-10

On-Brand Devices [MatriStem]

• 00386190000922: Surgical Matrix Plus 5 x 7 cm
• 00386190000915: Surgical Matrix Plus 7 x 10 cm
• 00386190000908: Surgical Matrix Plus 10 x 10 cm
• 00386190000892: Surgical Matrix Plus 10 x 15 cm
• 00386190000861: Pelvic Floor Matrix 10 x 15 cm
• 00386190000854: Pelvic Floor Matrix 7 x 10 cm
• 00386190000847: Pelvic Floor Matrix 5 x 5 cm
• 00386190000830: Pelvic Floor Matrix 4 x 12 cm
• 00386190000823: Multilayer Wound Matrix 10 X 15 cm
• 00386190000816: Multilayer Wound Matrix 7 X 10 cm
• 00386190000809: Multilayer Wound Matrix 5 X 5 cm
• 00386190000786: Burn Matrix Meshed 10X15cm
• 00386190000779: Burn Matrix Meshed 7X10cm
• 00386190000762: Burn Matrix Meshed 5X5cm
• 00386190000533: Pelvic Floor Matrix 9 x 12 cm
• 00386190000526: Surgical Matrix Thick 30 x 40 cm
• 00386190000519: Surgical Matrix Thick 30 x 30 cm
• 00386190000502: Surgical Matrix Thick 20 x 35 cm
• 00386190000496: Surgical Matrix Thick 20 x 30 cm
• 00386190000489: Surgical Matrix Thick 20 x 25 cm
• 00386190000472: Surgical Matrix Thick 20 x 20 cm
• 00386190000465: Surgical Matrix Thick 16 x 20 cm
• 00386190000458: Surgical Matrix Thick 10 x 20 cm
• 00386190000441: Surgical Matrix 10 x 15 cm
• 00386190000434: Surgical Matrix 8 x 16 cm
• 00386190000427: Surgical Matrix 6 x 15 cm
• 00386190000410: Surgical Matrix 7 x 10 cm
• 00386190000403: Surgical Matrix 5 x 5 cm
• 00386190000397: Surgical Matrix 4 x 12 cm
• 00386190000380: Surgical Matrix Thin 10 x 15 cm
• 00386190000373: Surgical Matrix Thin 7 x 15 cm
• 00386190000366: Surgical Matrix Thin 4 x 12 cm
• 00386190000359: Surgical Matrix Thin 6 x 15 cm
• 00386190000342: Surgical Matrix Thin 7 x 10 cm
• 00386190000335: Surgical Matrix Thin 5 x 5 cm
• 00386190000304: Surgical Matrix RS 10 x 15 cm
• 00386190000298: Surgical Matrix RS 8 x 16 cm
• 00386190000281: Surgical Matrix RS 6 x 15 cm
• 00386190000274: Surgical Matris RS 7 x 10 cm
• 00386190000267: Surgical Matrix RS 5 x 5 cm
• 00386190000250: Surgical Matrix RS 2 x 4 cm
• 00386190000229: MicroMatrix, 1000 mg
• 00386190000212: MicroMatrix, 500 mg
• 00386190000199: MicroMatrix, 200 mg Fine Particulate
• 00386190000182: MicroMatrix, 200 mg
• 00386190000168: MicroMatrix, 100 mg Fine Particulate
• 00386190000151: MicroMatrix, 100 mg
• 00386190000137: MicroMatrix, 60 mg
• 00386190000113: MatriStem Wound Sheet, 10 X 15 cm
• 00386190000090: MatriStem Wound Sheet, 7 X 10 cm