Phantom Fiber™ Suture - Needled

GUDID 00846832011698

TORNIER, INC.

Polyhydroxybutyrate suture

• Primary Device ID: 00846832011698
• NIH Device Record Key: 459f5499-2fc7-45a4-bce6-f78e3361e761
• Commercial Distribution Discontinuation: 2018-12-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Phantom Fiber™ Suture - Needled
• Version Model Number: SMSB0120N
• 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: 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(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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0
• Length: 91 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832011698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130422

FDA Product Code

• NWJ: Suture, recombinant technology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-17
• Device Publish Date: 2015-10-16

On-Brand Devices [Phantom Fiber™ Suture - Needled]

• 10846832011756: SMSB0132N
• 00846832011735: SMSB0130N
• 10846832011718: SMSB0122N
• 00846832011698: SMSB0120N
• 10846832011671: SMSB0112N
• 00846832011650: SMSB0110N