BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

ASCENDA®

DI: 00763000051136 · Model: 8782 · 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: 00763000051136
Version / Model: 8782
Company Name: MEDTRONIC, INC.
Labeler DUNS: 006261481
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-08-11
Public Version: 4
Public Version Date: 2025-12-16
Public Version Status: Update
Public Device Record Key: 0067f21e-066d-49e5-894f-798deac72cbb

Device Description

CATHETER 8782 ASCENDA SPINAL REV KIT

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: Yes
Has Lot/Batch Number: No
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	00763000051136	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P860004	294

Device Sizes

Type	Value	Unit	Text
Length	86.4	Centimeter

Storage Conditions

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