AccessGUDID - DEVICE: HUMAC Cybex NORM (R) (00860139000322)

GUDID

Device Identifier (DI) Information

Brand Name: HUMAC Cybex NORM (R)
Version or Model: 504192
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 504192
Company Name: COMPUTER SPORTS MEDICINE INC.

Primary DI Number: 00860139000322
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 059291894 *Terms of Use

Device Description: HUMAC Cybex NORM Extremity System; Dynamometer – Refurbished

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):	No
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?
34395	Back/leg/chest dynamometer	An analogue instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and leg muscles during flexion. It includes a force gauge, which may be attached to a handle or strap, to assess a variety of movements (e.g., leg abduction, lifting) and is typically used to test and control a patient's muscle strength as part of a rehabilitation program.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IKK	System, Isokinetic Testing And Evaluation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Relative Humidity for Storage and Handling is noncondensing
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d73b12c-b051-439d-abd8-a5a8eb7eedd8
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 14, 2016