INVISx™

GUDID 00643169466296

LOCKS 60101 INVISX - 1

MEDTRONIC PS MEDICAL, INC.

Cranial bone flap fixation clamp

• Primary Device ID: 00643169466296
• NIH Device Record Key: de37044c-ace3-49f1-966b-9717829b2464
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INVISx™
• Version Model Number: 60101
• 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: 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

Device Dimensions

• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter
• Width: 2.54 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169466296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010361

FDA Product Code

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

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: 2015-06-29

On-Brand Devices [INVISx™]

• 40613994845021: LOCK 60110 INVISX SHELF PK 10 X 2 PK
• 40643169496970: LOCK 60110 INVISX SHELF PK 10 X 2 PK
• 00643169466296: LOCKS 60101 INVISX - 1