OptiFix AT Absorbable Fixation System with Articulating Technology 0113315

GUDID 10801741136556

OptiFix AT Absorbable Fixation System with Articulating Technology – 15 absorbable fasteners

Davol Inc.

Soft-tissue/mesh anchor, bioabsorbable

• Primary Device ID: 10801741136556
• NIH Device Record Key: 7b881889-8149-4bb8-853d-909e4ba56255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiFix AT Absorbable Fixation System with Articulating Technology
• Version Model Number: 0113315
• Catalog Number: 0113315
• 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@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

• Length: 37 Centimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 37 Centimeter
• Outer Diameter: 5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741136559 [Primary]
GS1	10801741136556 [Package]; Contains: 00801741136559; Package: CA [5 Units]; In Commercial Distribution

FDA Product Code

• GDW: Staple, implantable

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: 2019-07-26
• Device Publish Date: 2019-07-18

On-Brand Devices [OptiFix AT Absorbable Fixation System with Articulating Technology]

• 10801741136563: OptiFix AT Absorbable Fixation System with Articulating Technology - 30 absorbable fasteners
• 10801741136556: OptiFix AT Absorbable Fixation System with Articulating Technology – 15 absorbable fasteners