MatriDerm 83500-300

GUDID 04250569301766

MedSkin Solutions Dr. Suwelack AG

Collagen wound matrix dressing

• Primary Device ID: 04250569301766
• NIH Device Record Key: 109be4c8-295d-45bb-8404-95c2be5735af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MatriDerm
• Version Model Number: 83500-300
• Catalog Number: 83500-300
• 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
• 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
• 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: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 Centimeter
• Height: 0.1 Centimeter
• Length: 21 Centimeter
• Width: 29.7 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
• 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
• 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	04250569301766 [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: 2021-10-15

On-Brand Devices [MatriDerm]

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