LinkStation MINI 05000-001

GUDID 00816818020440

LinkStation MINI with United States and Canada power cord

ORTHOSENSOR INC

Arthroplasty force sensor display unit
Primary Device ID00816818020440
NIH Device Record Keyb4b3e842-14bb-464b-a302-296aa730db35
Commercial Distribution StatusIn Commercial Distribution
Brand NameLinkStation MINI
Version Model NumberLinkStation MINI
Catalog Number05000-001
Company DUNS005788130
Company NameORTHOSENSOR INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816818020440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONNIntraoperative Orthopedic Joint Assessment Aid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-05-02

On-Brand Devices [LinkStation MINI]

00816818020495LinkStation MINI with Switzerland power cord
00816818020488LinkStation MINI with Italy power cord
00816818020471LinkStation MINI with United Kingdom and Ireland power cord
00816818020464LinkStation MINI with Continental Europe/ Korea power cord
00816818020457LinkStation MINI with Australia and New Zealand power cord
00816818020440LinkStation MINI with United States and Canada power cord
00816818020006LinkStation MINI with Continental Europe/ Korea power cord and additional label for Korea
00816818022536LinkStation MINI with United States and Canada power cord. Bluetooth only

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