DEVICE: N/A (00613994806611)

Device Identifier (DI) Information

N/A
46420
In Commercial Distribution

MEDTRONIC PS MEDICAL, INC.
00613994806611
GS1

1
089055867 *Terms of Use
CATH 46420 EDM LUMBAR 80CM/OPEN TIP
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JXG Shunt, central nervous system and components
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K862303 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 0.7 Millimeter
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Device Record Status

ff4eeb44-2522-4b5b-8317-8e5beafbbaf4
December 23, 2024
5
August 20, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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