DEVICE: CARDINAL HEALTH (00887488022287)

Device Identifier (DI) Information

CARDINAL HEALTH
PN5ACRKSK
In Commercial Distribution
PN5ACRKSK
CARDINAL HEALTH 200, LLC
00887488022287
GS1

1
112164780 *Terms of Use
KIT,CRANIOTOMY
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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
Craniotomy kit A collection of various sterile basic instruments, dressings and the necessary materials used to perform a craniotomy procedure. It typically includes scalpels, retractors, forceps, sutures, but does not contain pharmaceuticals. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
OJG Neurological tray
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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

[?]
Size Type Text
No Device Sizes
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Device Record Status

f40f08a9-d7f2-4c9f-9b6e-a8564fb304d3
March 29, 2018
2
July 30, 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
50887488022282 1 00887488022287 In Commercial Distribution CASE
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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
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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