METRx® System

GUDID 00673978085593

INSTRUMENT 9560160 16MM MTRXND ATCH STRL

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00673978085593
• NIH Device Record Key: 242534ff-7d7b-42e7-93c2-13cd053b2802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: METRx® System
• Version Model Number: 9560160
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978085593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993021

FDA Product Code

• HRX: ARTHROSCOPE

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: 2016-09-30

On-Brand Devices [METRx® System]

• 00613994415868: RETRACTOR X1007055 MX TUBE 26MM X 10CM
• 00613994393623: RETRACTOR X0907067 25MM X 9CM EXPANDING
• 00613994312129: TUBE 9565670 16MMX3CM COATED
• 00613994312112: TUBE 9565671 16MMX4CM COATED
• 00613994312105: TUBE 9565672 16MMX5CM COATED
• 00613994312099: TUBE 9565673 16MMX6CM COATED
• 00613994312082: TUBE 9565674 16MMX7CM COATED
• 00613994312075: TUBE 9565675 16MMX8CM COATED
• 00613994312068: TUBE 9565676 16MMX9CM COATED
• 00613994312051: TUBE 9565666 14MMX9CM COATED
• 00613994312044: TUBE 9565665 14MMX8CM COATED
• 00613994312037: TUBE 9565664 14MMX7CM COATED
• 00613994312020: TUBE 9565663 14MMX6CM COATED
• 00613994312013: TUBE 9565662 14MMX5CM COATED
• 00613994312006: TUBE 9565661 14MMX4CM COATED
• 00613994311993: TUBE 9565660 14MMX3CM COATED
• 00613994311986: TUBE 9565726 20MMX9CM COATED
• 00613994311979: TUBE 9565725 20MMX8CM COATED
• 00613994311962: TUBE 9565724 20MMX7CM COATED
• 00613994311955: TUBE 9565723 20MMX6CM COATED
• 00613994311948: TUBE 9565722 20MMX5CM COATED
• 00613994311931: TUBE 9565721 20MMX4CM COATED
• 00613994311924: TUBE 9565720 20MMX3CM COATED
• 00613994311900: TUBE 9565685 18MMX8CM COATED
• 00613994311894: TUBE 9565684 18MMX7CM COATED
• 00613994311887: TUBE 9565683 18MMX6CM COATED
• 00613994311870: TUBE 9565682 18MMX5CM COATED
• 00613994311863: TUBE 9565681 18MMX4CM COATED
• 00613994311856: TUBE 9565680 18MMX3CM COATED
• 00613994286291: RETRACTOR X1106107 18MM X 9CM TUBE
• 00673978961170: CASE 9560698 METRX MD BASE CASE
• 00673978085609: INSTRUMENT 9560180 18MM MTRXND ATCH STRL
• 00673978085593: INSTRUMENT 9560160 16MM MTRXND ATCH STRL
• 00673978085524: INSTRUMENT 9560107 3 CHIP CAM ADPTR
• 00673978085487: SCOPE 9560102 MTRX REUSE ENDOSCOPE LONG
• 00721902949180: 18MM RADIANCE ILLUM. SYSTEM
• 00721902663444: INSTRUMENT 9560757 RDINCEXILLUMIN SYS
• 00721902444104: INSTRUMENT 9560702 RADIANCE ILLUMIN SYS
• 00885074458861: TUBE 9569756 26MM X 9CM COATED
• 00885074458847: TUBE 9569755 26MM X 8CM COATED
• 00885074458830: TUBE 9569754 26MM X 7CM COATED
• 00885074458816: TUBE 9569753 COATED 26MM X 6CM
• 00885074458809: TUBE 9569752 COATED 26MMX5CM
• 00885074458786: TUBE 9569751 COATED 26MM X 4CM
• 00885074458779: TUBE 9569750 COATED 26MM X 3CM
• 00885074458724: TUBE 9569736 22MM X 9CM COATED
• 00885074458700: TUBE 9569735 22MM X 8CM COATED
• 00885074458694: TUBE 9569734 22MM X 7CM COATED
• 00885074458663: TUBE 9569733 22MM X 6CM COATED
• 00885074458649: TUBE 9569732 22MM X 5CM COATED