Exacta™

GUDID 00643169213883

CLAMP 46715 EXACTA PL NEG 25CM W/LSR

MEDTRONIC PS MEDICAL, INC.

Laser patient positioning system

• Primary Device ID: 00643169213883
• NIH Device Record Key: cc9a00b5-5b39-4828-96ac-e5be237b4681
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exacta™
• Version Model Number: 46715
• 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	00643169213883 [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: 2015-07-07

On-Brand Devices [Exacta™]

• 00613994857996: CLAMP 46717 EXACTA POLE -25CM W/O LSR
• 00643169990906: CLAMP 46717 EXACTA POLE -25CM W/O LSR
• 00643169990890: ASSY 46713 EXACTA POLE CLAMP NO LASER
• 00643169707665: SYSTEM 46700 EXACTA DISP. DRAINAGE
• 00643169497993: ASSY 46711 EXACTA POLE CLAMP W/LASER
• 00643169497986: ASSY 46713 EXACTA POLE CLAMP NO LASER
• 00643169497979: CLAMP 46715 EXACTA PL NEG 25CM W/LSR
• 00643169497962: CLAMP 46717 EXACTA POLE -25CM W/O LSR
• 00643169213883: CLAMP 46715 EXACTA PL NEG 25CM W/LSR
• 00643169213876: ASSY 46711 EXACTA POLE CLAMP W/LASER
• 00681490871709: SYSTEM 46705 EXACTA DRAINAGE 100ML
• 00681490611176: BAG 27654 EXACTA W/DRAINPORT GLUED ON
• 00681490535649: CLAMP 46715 EXACTA PL NEG 25CM W/LSR
• 00681490533928: EDM 27636 EXACTA W/BRAIDED CORD LOCK
• 00681490462372: EDMS 27579 EXACTA W/ PATIENT LINE Y-PORT
• 00673978925394: KIT 27581 EXACTA W/EDM VCATH 35CM
• 00673978779560: ASSY 46713 EXACTA POLE CLAMP NO LASER
• 00673978779553: BAG 46712 EXACTA DRAINAGE 10 PK
• 00673978779539: BAG 46710 EXACTA DRAINAGE
• 00673978229171: SYSTEM 46700 EXACTA DISP. DRAINAGE
• 00721902608537: EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP
• 00721902060083: KIT 27673 EXACTA W/EDM VCATH BIOGL 35CM
• 00721902035173: EDM 27666 EXCTA W GLUE STPCK GR PT LN
• 00885074530017: EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL
• 00885074280349: EDMS 27795 EXACTA 100ML CATH
• 00885074051802: EDMS 27785 EXACTA 50ML BC NDLESS INJ
• 00763000164416: ASSY 46711 EXACTA POLE CLAMP W/LASER
• 00763000164423: CLAMP 46715 EXACTA PL NEG 25CM W/LSR
• 00763000333690: SYSTEM 46700 EXACTA DISP. DRAINAGE
• 00763000333546: KIT 27673 EXACTA W/EDM VCATH BIOGL 35CM
• 00763000431280: BAG 46710 EXACTA DRAINAGE