Collage

GUDID 18257200121861

Osteoconductive Scaffold Strip 10 cc

ORTHOFIX INC.

Bone matrix implant, composite

• Primary Device ID: 18257200121861
• NIH Device Record Key: 64136412-8ab9-42fa-b311-50d5152af663
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Collage
• Version Model Number: 711010
• Company DUNS: 927083808
• Company Name: ORTHOFIX INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.c
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.c
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com
• Phone: 1(214)937-3199
• Email: osi-customerservice@orthofix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200121861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063124

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2016-09-14

On-Brand Devices [Collage]

• 18257200121878: Osteoconductive Scaffold Strip, 15cc
• 18257200121861: Osteoconductive Scaffold Strip 10 cc
• 18257200115136: Collage Osteoconductive Scaffold Putty 15cc
• 18257200115129: Collage Osteoconductive Scaffold Putty 10 cc
• 18257200115112: Collage Osteoconductive Scaffold Putty, 5cc