DEVICE: Exacta™ (00673978925394)

Device Identifier (DI) Information

Exacta™
27581
In Commercial Distribution

MEDTRONIC PS MEDICAL, INC.
00673978925394
GS1

1
089055867 *Terms of Use
KIT 27581 EXACTA W/EDM VCATH 35CM
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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?
61798 Ventricular cerebrospinal fluid drainage catheterization kit
A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF) as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). 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
GWM DEVICE, MONITORING, INTRACRANIAL PRESSURE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K984053 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
No Device Sizes
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Device Record Status

ef21b530-5965-4216-9b17-d1d40de1ce93
December 23, 2024
4
July 14, 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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