BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Ascenda®

DI: 00763000852597 · Model: 8780 · MEDTRONIC, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Ascenda®
Primary DI: 00763000852597
Version / Model: 8780
Company Name: MEDTRONIC, INC.
Labeler DUNS: 796986144
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2023-12-09
Public Version: 3
Public Version Date: 2025-10-09
Public Version Status: Update
Public Device Record Key: 1ae50295-29b6-4c7e-a44d-3fc76f1f055a
Distribution End Date: 2025-10-07

Device Description

CATH 8780 ASCENDA INTRATHECAL 86CM EMAN

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: Yes
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKK	Pump, infusion, implanted, programmable	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61797	Lumbar cerebrospinal fluid drainage catheterization kit	A collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF) as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, filter). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000852597	GS1

Customer Contacts

Phone: +1(800)633-8766
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P860004	415

Device Sizes

Type	Value	Unit	Text
Length	86.4	Centimeter
Length	27.9	Centimeter

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -34 – 57 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -30 – 135 Degrees Fahrenheit