Clear-Site®

GUDID 00613994450661

EDMS 46918 CLEAR-SITE LASER LEVEL

MEDTRONIC PS MEDICAL, INC.

Laser patient positioning system

• Primary Device ID: 00613994450661
• NIH Device Record Key: 3c014941-a11c-4bed-bc2d-a3b457856e0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clear-Site®
• Version Model Number: 46918
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994450661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984053

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-16

On-Brand Devices [Clear-Site®]

• 00613994450661: EDMS 46918 CLEAR-SITE LASER LEVEL
• 00643169497955: EDMS 46918 CLEAR-SITE LASER LEVEL
• 00763000169893: EDMS 46918 CLEAR-SITE LASER LEVEL
• 00763000281267: EDMS 46918 CLEAR-SITE LASER LEVEL