DEVICE: CARDINAL HEALTH (00887488022300)

Device Identifier (DI) Information

CARDINAL HEALTH
PG5AMJKSJ
In Commercial Distribution
PG5AMJKSJ
Cardinal Health 200, LLC
00887488022300
GS1

1
961027315 *Terms of Use
KIT,G U MAJOR
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Urological surgical procedure kit, non-medicated, single-use A collection of various sterile urological surgical instruments and the necessary materials intended to be used to perform a urological surgical procedure. The kit is not dedicated to a specific type of urological surgical procedure and does not contain any pharmaceuticals. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
NWU Kit, introducer, endoscope
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

96ddcbf4-0068-4c7f-8b9d-ebdbbd36e8ac
July 17, 2018
3
October 02, 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
50887488022305 1 00887488022300 In Commercial Distribution CASE
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Secondary DI

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

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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

[?]
No Customer Contact currently defined
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