AccessGUDID - DEVICE: Linkstation MINI Evaluation Kit (00816818022635)

GUDID

Device Identifier (DI) Information

Brand Name: Linkstation MINI Evaluation Kit
Version or Model: Linkstation MINI Evaluation Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 05000-500-B
Company Name: ORTHOSENSOR INC

Primary DI Number: 00816818022635
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 005788130 *Terms of Use

Device Description: LinkStation MINI Evaluation Kit with power cord for United States and Canada. Bluetooth only.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
ONN	Intraoperative Orthopedic Joint Assessment Aid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200665	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ee113292-885b-423f-b033-8e6348988b92
Public Version Date: July 10, 2023
Public Version Number: 3
DI Record Publish Date: April 28, 2021