Kontour Matrix

GUDID 04250830900636

Collagen membrane

Matricel GmbH

Collagen dental regeneration membrane

• Primary Device ID: 04250830900636
• NIH Device Record Key: 7e1d5497-daac-484a-b13b-58fe93c4e9b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kontour Matrix
• Version Model Number: KMAX2530
• Company DUNS: 344166512
• Company Name: Matricel GmbH
• 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: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com
• Phone: +49240756440
• Email: info@matricel.com

Device Dimensions

• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter
• Area/Surface Area: 750 Square millimeter

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
• 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	04250830900636 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123697

FDA Product Code

• NPL: Barrier, Animal Source, Intraoral

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: 2022-02-08
• Device Publish Date: 2022-01-31

On-Brand Devices [Kontour Matrix]

• 04250830900643: Collagen membrane
• 04250830900636: Collagen membrane
• 04250830900629: Collagen membrane