HUMAC NORM (R) 504191

GUDID 00860139000315

HUMAC NORM Extremity System; Dynamometer – Refurbished

COMPUTER SPORTS MEDICINE INC.

Back/leg/chest dynamometer
Primary Device ID00860139000315
NIH Device Record Key558ea91e-e215-4a30-ac07-88998c69df1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHUMAC NORM (R)
Version Model Number504191
Catalog Number504191
Company DUNS059291894
Company NameCOMPUTER SPORTS MEDICINE 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-297-2034
Emaildev@csmisolutions.com

Operating and Storage Conditions

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100860139000315 [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 Date2018-03-29
Device Publish Date2016-09-14

Devices Manufactured by COMPUTER SPORTS MEDICINE INC.

00860139000308 - HUMAC NORM2018-03-29 HUMAC NORM Extremity System; Dynamometer
00860139000315 - HUMAC NORM (R)2018-03-29HUMAC NORM Extremity System; Dynamometer – Refurbished
00860139000315 - HUMAC NORM (R)2018-03-29 HUMAC NORM Extremity System; Dynamometer – Refurbished
00860139000322 - HUMAC Cybex NORM (R)2018-03-29 HUMAC Cybex NORM Extremity System; Dynamometer – Refurbished
00860139000339 - HUMAC Biodex System2 (R)2018-03-29 HUMAC Biodex System2 Extremity System; Dynamometer – Refurbished
00860139000346 - HUMAC Biodex System3 Rev0 (R)2018-03-29 HUMAC Biodex System3 Rev0 Extremity System; Dynamometer – Refurbished
00860139000353 - HUMAC Biodex System3 Rev1 (R)2018-03-29 HUMAC Biodex System3 Rev1 Extremity System; Dynamometer – Refurbished
00860139000360 - HUMAC Biodex System42018-03-29 HUMAC Biodex System4 Extremity System; Dynamometer – Refurbished

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