Ascenda

GUDID 00613994555632

NEEDLE 8786 CATHETER SHORT

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 00613994555632
• NIH Device Record Key: f400976e-fd97-41b2-8dae-cf06016d0336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascenda
• Version Model Number: 8786
• Company DUNS: 796986144
• Company Name: MEDTRONIC, 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

Device Dimensions

• Length: 9 Centimeter
• Length: 9 Centimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Handling Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994555632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860004

FDA Product Code

• LKK: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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: 2014-09-23

On-Brand Devices [Ascenda]

• 00613994555632: NEEDLE 8786 CATHETER SHORT
• 00613994555625: CATH 8784 ASCENDA PROXIMAL REV KIT EMAN
• 00613994555618: CATH 8782 ASCENDA SPINAL REV SHORT EMAN
• 00613994555601: CATH 8781 ASCENDA INTRATHECAL LONG EMAN
• 00613994555595: CATH 8780 ASCENDA INTRATHECAL SHORT EMAN
• 00613994408495: ACCESSORY 8785 CATHETER