CannuLink™

GUDID 00846832035663

TORNIER, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00846832035663
• NIH Device Record Key: c219e9f7-aba8-4740-8d04-b08c830b143c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CannuLink™
• Version Model Number: IFS-010-29N-16S
• Company DUNS: 968990812
• Company Name: TORNIER, 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: false
• 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(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com

Device Dimensions

• Length: 16 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2.9 Millimeter
• Length: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832035663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141004

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

[00846832035663]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-16

On-Brand Devices [CannuLink™]

• 00846832035670: IFS-010-29N-19S
• 00846832035663: IFS-010-29N-16S
• 00846832035656: IFS-010-29N
• 00846832035649: IFS-010-29A
• 00846832035601: IFS-010-29
• 00846832035595: IFS-010-27N-18S
• 00846832035588: IFS-010-27N-15S
• 00846832035571: IFS-010-27N
• 00846832035557: IFS-010-24N-18S
• 00846832035540: IFS-010-24N-15S
• 00846832035533: IFS-010-24N
• 00846832035526: IFS-010-24A
• 00846832035489: IFS-010-24
• 00846832035472: IFS-010-22A
• 00846832035441: IFS-010-22
• 00846832035199: IFP-010-29
• 00846832035175: IFP-010-27
• 00846832035151: IFP-010-24
• 00846832035137: IFP-010-22