MatriDerm 83403-300

GUDID 04250569301742

MedSkin Solutions Dr. Suwelack AG

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: 04250569301742
• NIH Device Record Key: 48223831-8298-487f-87f6-6e9740bbfb6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MatriDerm
• Version Model Number: 83403-300
• Catalog Number: 83403-300
• Company DUNS: 318479870
• Company Name: MedSkin Solutions Dr. Suwelack AG
• 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: 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: +18776321017
• Email: xx@xx.xx
• Phone: +18776321017
• Email: xx@xx.xx
• Phone: +18776321017
• Email: xx@xx.xx
• Phone: +18776321017
• Email: xx@xx.xx
• Phone: +18776321017
• Email: xx@xx.xx
• Phone: +18776321017
• Email: xx@xx.xx
• Phone: +18776321017
• Email: xx@xx.xx
• Phone: +18776321017
• Email: xx@xx.xx
• Phone: +18776321017
• Email: xx@xx.xx

Device Dimensions

• Height: 0.1 Centimeter
• Length: 10.1 Centimeter
• Width: 14.8 Centimeter
• Height: 0.1 Centimeter
• Length: 10.1 Centimeter
• Width: 14.8 Centimeter
• Height: 0.1 Centimeter
• Length: 10.1 Centimeter
• Width: 14.8 Centimeter
• Height: 0.1 Centimeter
• Length: 10.1 Centimeter
• Width: 14.8 Centimeter
• Height: 0.1 Centimeter
• Length: 10.1 Centimeter
• Width: 14.8 Centimeter
• Height: 0.1 Centimeter
• Length: 10.1 Centimeter
• Width: 14.8 Centimeter
• Height: 0.1 Centimeter
• Length: 10.1 Centimeter
• Width: 14.8 Centimeter
• Height: 0.1 Centimeter
• Length: 10.1 Centimeter
• Width: 14.8 Centimeter
• Height: 0.1 Centimeter
• Length: 10.1 Centimeter
• Width: 14.8 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250569301742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201577

FDA Product Code

• KGN: Dressing, Wound, Collagen

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: 2021-10-25
• Device Publish Date: 2021-10-16

On-Brand Devices [MatriDerm]

• 04250569301780: 83405-300
• 04250569301773: 83400-300
• 04250569301766: 83500-300
• 04250569301759: 83401-300
• 04250569301742: 83403-300
• 04250569301735: 83404-300