xenoPATCH™ XPM55

GUDID 00812337020602

DSM BIOMEDICAL, INC.

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 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	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

Trademark Results [xenoPATCH]

Mark Image Registration \| Serial	Company Trademark Application Date
XENOPATCH 98235236 not registered Live/Pending	Extremity Care, LLC 2023-10-23