Clear-Site®

GUDID 00643169497955

EDMS 46918 CLEAR-SITE LASER LEVEL

MEDTRONIC PS MEDICAL, INC.

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• Primary Device ID: 00643169497955
• NIH Device Record Key: 03cc71e8-f97b-4566-b10c-08db9ab0d46a
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169497955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983799

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-16

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