OptiFix Open Absorbable Fixation System 0113320

GUDID 10801741128957

OptiFix Open Absorbable Fixation System

Davol Inc.

Soft-tissue/mesh anchor, bioabsorbable

• Primary Device ID: 10801741128957
• NIH Device Record Key: 898b5066-53d3-47bd-8f67-a8d52f6e6fc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiFix Open Absorbable Fixation System
• Version Model Number: 0113320
• Catalog Number: 0113320
• 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

• Length: 27 Centimeter
• Length: 27 Centimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 27 Centimeter
• Outer Diameter: 5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741128950 [Primary]
GS1	10801741128957 [Package]; Contains: 00801741128950; Package: BX [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-08
• Device Publish Date: 2018-01-10

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• 00801741200755 - 3DMax™ MID Anatomical Mesh: 2020-08-04 3DMax™ MID Anatomical Mesh, Large, Left, 4" x 6", 10 x 16 cm
• 00801741200762 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, XL, Left, 5” x 7”, 12 x 17 cm
• 00801741200779 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, Medium, Right, 3" x 5", 8 x 13 cm
• 00801741200786 - 3DMax™ MID Anatomical Mesh: 2020-08-03 3DMax™ MID Anatomical Mesh, Large, Right, 4” x 6”, 10 x 16 cm