INVISx™

GUDID 00643169466296

LOCKS 60101 INVISX - 1

MEDTRONIC PS MEDICAL, INC.

Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip

• 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