EndoAvitene 1010260

GUDID 10801741010498

EndoAvitene Microfibrillar Collagen Hemostat in an Endoscopic Delivery System

Davol Inc.

Collagen haemostatic agent

• Primary Device ID: 10801741010498
• NIH Device Record Key: a36f8543-1056-49b2-b29d-fb802b9fc76c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoAvitene
• Version Model Number: 1010260
• Catalog Number: 1010260
• Company DUNS: 001191048
• Company Name: Davol 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: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com

Device Dimensions

• Depth: 1 Millimeter
• Depth: 1 Millimeter
• Depth: 1 Millimeter
• Depth: 1 Millimeter
• Depth: 1 Millimeter
• Depth: 1 Millimeter
• Depth: 1 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5 Millimeter
• Width: 5 Millimeter
• Depth: 1 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741010491 [Primary]
GS1	10801741010498 [Package]; Contains: 00801741010491; Package: CA [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P800002

FDA Product Code

• LMF: Agent, absorbable hemostatic, collagen based

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-12

On-Brand Devices [EndoAvitene]

• 10801741010498: EndoAvitene Microfibrillar Collagen Hemostat in an Endoscopic Delivery System
• 10801741010481: EndoAvitene Microfibrillar Collagen Hemostat in an Endoscopic Delivery System