INVISx®

GUDID 00643169498006

INSTR 60710 INVISX TENSIONING REUSE

MEDTRONIC PS MEDICAL, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00643169498006
• NIH Device Record Key: eb1ab51b-92a7-4c92-a9bb-1a8eabe92a3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVISx®
• Version Model Number: 60710
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169498006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010361

FDA Product Code

• GXN: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Sterilization

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

[00643169498006]

Moist Heat or Steam Sterilization

[00643169498006]

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: 2015-06-24

On-Brand Devices [INVISx®]

• 00643169103467: INSTR 60710 INVISX TENSIONING REUSE
• 00643169498242: SET 60700 INVISX CRNL FXTION INSTR
• 00643169498006: INSTR 60710 INVISX TENSIONING REUSE
• 00643169497771: TRAY 60730 INVISX INSTRUMENT
• 20643169466306: LOCKS 60100 INVISX 2PK CE
• 00681490881579: TRAY 60730 INVISX INSTRUMENT
• 00681490881555: INSTRUMENT 60720 INVISX TRIMMING REU
• 00681490881470: SET 60700 INVISX CRNL FXTION INSTR