careLAGEN

GUDID 50850003042225

careLAGEN Collagen Matrix Dressing 2" X 2"

Extremity Care

Collagen wound matrix dressing

• Primary Device ID: 50850003042225
• NIH Device Record Key: 375cf4c6-b398-4e2b-81de-c5a323402397
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: careLAGEN
• Version Model Number: EC008
• Company DUNS: 086365085
• Company Name: Extremity Care
• 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: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com
• Phone: 1-888-694-6694
• Email: customerservice@extremitycare.com

Device Dimensions

• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch
• Width: 2 Inch
• Length: 2 Inch

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003042220 [Primary]
GS1	50850003042225 [Package]; Contains: 00850003042220; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171645

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

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: 2023-02-10
• Device Publish Date: 2023-02-02

On-Brand Devices [careLAGEN]

• 50850003042225: careLAGEN Collagen Matrix Dressing 2" X 2"
• 50850003042201: careLAGEN Collagen Powder 1g
• 00850003042329: careLAGEN 7" x 7" Collagen Matrix Wound Dressing