InvisX

GUDID 00643169497788

INSTRUMENT 60720 INVISX TRIMMING REU

MEDTRONIC PS MEDICAL, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00643169497788
• NIH Device Record Key: 35a615d5-80a9-42c0-b9e7-ca496515e3ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InvisX
• Version Model Number: 60720
• 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	00643169497788 [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

[00643169497788]

Moist Heat or Steam Sterilization

[00643169497788]

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: 2016-08-05

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• 00763000333461 - Exacta™: 2024-12-23 EDMS 27579 EXACTA W/ PATIENT LINE Y-PORT
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• 00763000333492 - Exacta™: 2024-12-23 EDM 27636 EXACTA W/BRAIDED CORD LOCK
• 00763000333508 - Exacta™: 2024-12-23 BAG 27654 EXACTA W/DRAINPORT GLUED ON
• 00763000333515 - Exacta™: 2024-12-23 EDM 27666 EXCTA W GLUE STPCK GR PT LN