DEVICE: LinkStation MINI Evaluation Kit (00816818020518)

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Device Record History
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Device Identifier (DI) Information
LinkStation MINI Evaluation Kit
LinkStation MINI Evaluation Kit
Not in Commercial Distribution
05000-502
ORTHOSENSOR INC
00816818020518
GS1
June 30, 2023
1
005788130 *Terms of Use
LinkStation MINI Evaluation Kit with Australia and New Zealand power cord
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
62563 Arthroplasty force sensor display unit
An electrically-powered electronic device designed to wirelessly connect to an arthroplasty force sensor to display sensor readings in a graphical representation to facilitate assessment of bone resection lines and/or size or positioning of prosthesis components to be implanted. It consists of a computing device with installed dedicated application software, which may have a dedicated receiver.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ONN Intraoperative Orthopedic Joint Assessment Aid
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
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

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Size Type Text
No Device Sizes
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Device Record Status
59d6b3c7-158a-40bd-942e-668d5d2c8add
July 31, 2023
6
February 20, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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