MJS System 3 Upgrade 850-822

GUDID 00718175004067

Biodex Multi-Joint-System 3 Rev.1 UpGrade

BIODEX MEDICAL SYSTEMS, INC.

Biomechanical function analysis system, force-testing, stationary
Primary Device ID00718175004067
NIH Device Record Keydeb0798e-a553-4ce1-bfca-fe95a41e838a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMJS System 3 Upgrade
Version Model Number850-822
Catalog Number850-822
Company DUNS043833813
Company NameBIODEX MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100718175004067 [Primary]

FDA Product Code

IKKSystem, Isokinetic Testing And Evaluation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-27
Device Publish Date2018-08-10

On-Brand Devices [MJS System 3 Upgrade]

00718175004067Biodex Multi-Joint-System 3 Rev.1 UpGrade
00718175004050BIODEX SYSTEM 3 REMANUFACTURE

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