DEVICE: Integral Drainage Set (10381780034179)

Device Identifier (DI) Information

Integral Drainage Set
910400
Not in Commercial Distribution
910400
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
10381780034179
GS1
December 31, 2018
1
531408342 *Terms of Use
Two three-way Stopcock Protection Boxes.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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?
35375 Stopcock
A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. 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 [?]
K924600 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
Device Size Text, specify: N/A
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Device Record Status

7f44609e-4ebe-4566-8864-b571c3b387c3
February 10, 2023
4
October 01, 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
30381780034173 2 10381780034179 2018-12-31 Not in Commercial Distribution BOX
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
HIBCC M2729104001
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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
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)654-2873
custsvcnj@integralife.com
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