careLAGEN

GUDID 50850003042201

careLAGEN Collagen Powder 1g

Extremity Care

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: 50850003042201
• NIH Device Record Key: 36082c95-8423-4baf-9aa0-55b05860b456
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: careLAGEN
• Version Model Number: EC004
• 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

• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram

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	00850003042206 [Primary]
GS1	50850003042201 [Package]; Contains: 00850003042206; 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