xenoPATCH™ XPM55

GUDID 00812337020602

DSM BIOMEDICAL, INC.

Collagen wound matrix dressing

• Primary Device ID: 00812337020602
• NIH Device Record Key: c792956b-c9cd-46c5-a447-d0a406a4af34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: xenoPATCH™
• Version Model Number: 30052-32
• Catalog Number: XPM55
• Company DUNS: 131107757
• Company Name: DSM BIOMEDICAL, 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: 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: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com
• Phone: 484-713-2100
• Email: ClinReg.ExtonPA@dsm-firmenich.com

Device Dimensions

• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter
• Length: 5 Centimeter
• Width: 5 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812337020602 [Primary]

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: 2023-12-20
• Device Publish Date: 2023-12-12

Devices Manufactured by DSM BIOMEDICAL, INC.

• 00812337020541 - Resolve Matrix™ Biologic Membrane: 2023-12-26 Resolve Matrix™ 2 cm x 2 cm
• 00812337020558 - Resolve Matrix™ Biologic Membrane: 2023-12-26 Resolve Matrix™ 2 cm x 4 cm
• 00812337020565 - Resolve Matrix™ Biologic Membrane: 2023-12-26 Resolve Matrix™ 4 cm x 5 cm
• 00812337020572 - Resolve Matrix™ Biologic Membrane: 2023-12-26 Resolve Matrix™ 6 cm x 8 cm
• 00812337020589 - Resolve Matrix™ Biologic Membrane: 2023-12-26 Resolve Matrix™ 2 cm x 3 cm
• 00812337020596 - Resolve Matrix™ Biologic Membrane: 2023-12-26 Resolve Matrix™ 3 cm x 4 cm
• 00812337020602 - xenoPATCH™: 2023-12-20
• 00812337020602 - xenoPATCH™: 2023-12-20
• M263W25000 - WizardBio Resorbable Calcium Phosphate Cement: 2023-06-20 WizardBio Resorbable Calcium Phosphate Cement