Compression Staple System

GUDID 00846832058969

TORNIER, INC.

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

• Primary Device ID: 00846832058969
• NIH Device Record Key: 6469a77f-9b15-4eea-b7e9-68b2cab35d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compression Staple System
• Version Model Number: STP-003-252520
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Width: 25 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832058969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130832

FDA Product Code

• JDR: STAPLE, FIXATION, BONE

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: 2015-10-16

On-Brand Devices [Compression Staple System]

• 00846832058976: STP-003-252522
• 00846832058969: STP-003-252520
• 00846832058952: STP-003-252516
• 00846832058945: STP-003-252222
• 00846832058938: STP-003-252220
• 00846832058921: STP-003-252121
• 00846832058914: STP-003-252020
• 00846832058907: STP-003-252016
• 00846832058891: STP-003-202520
• 00846832058884: STP-003-202424
• 00846832058877: STP-003-202323
• 00846832058860: STP-003-202222
• 00846832058853: STP-003-202220
• 00846832058846: STP-003-202121
• 00846832058839: STP-003-202016
• 00846832058822: STP-003-191919
• 00846832058815: STP-003-191814
• 00846832058808: STP-003-191812
• 00846832058792: STP-003-191717
• 00846832058785: STP-003-191616
• 00846832058778: STP-003-191520
• 00846832058761: STP-003-191512
• 00846832058754: STP-003-191510
• 00846832058747: STP-003-161414
• 00846832058730: STP-003-161410
• 00846832058723: STP-003-161313
• 00846832058716: STP-003-161210
• 00846832058709: STP-003-161111
• 00846832058693: STP-003-160909
• 00846832055302: STP-003-202522
• 00846832055272: STP-003-202020
• 00846832055227: STP-003-191818
• 00846832055180: STP-003-191515
• 00846832055159: STP-003-161212
• 00846832055128: STP-003-161010
• 00846832055098: STP-003-160808
• 00846832056262: DRILL GUIDE TIP
• 00846832056255: DRILL GUIDE TIP
• 00846832056248: DRILL GUIDE TIP
• 00846832056231: DRILL GUIDE TIP
• 00846832056224: DRILL GUIDE TIP
• 00846832056217: DRILL GUIDE TIP
• 00846832056194: DRILL GUIDE TIP
• 00846832056187: DRILL GUIDE TIP
• 00846832056170: DRILL GUIDE TIP
• 00846832056163: DRILL GUIDE TIP
• 00846832056149: DRILL GUIDE TIP
• 00846832056125: DRILL GUIDE TIP
• 00846832056118: DRILL GUIDE TIP
• 00846832056095: DRILL GUIDE TIP