DEVICE: CARDINAL HEALTH (10887488662923)

Device Identifier (DI) Information

CARDINAL HEALTH
SOPOCTJUCA
In Commercial Distribution
SOPOCTJUCA
Cardinal Health 200, LLC
10887488662923
GS1

1
961027315 *Terms of Use
STERILE TOTAL JOINT PACK
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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
Orthopaedic surgical procedure kit, non-medicated, single-use A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
OJH Orthopedic 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
No storage/handling found
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Clinically Relevant Size

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

43845b23-b4c8-403f-b689-2ace9b393328
July 20, 2018
3
February 04, 2017
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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
50887488662921 1 10887488662923 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

[?]
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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