AccessGUDID - DEVICE: MCU Multi-Cervical Unit (10850390007427)

GUDID

Device Identifier (DI) Information

Brand Name: MCU Multi-Cervical Unit
Version or Model: MCU 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BTE TECHNOLOGIES, INC.

Primary DI Number: 10850390007427
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021461470 *Terms of Use

Device Description: A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes.

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?
35699	Neck mechanical weight exerciser	A mechanical exercise apparatus intended primarily to strengthen the major muscles of the neck (e.g., sternocleidomastoid, splenius capitis and cervicis/colli) through repetitive flexion or extension of the neck muscles against the force of a weight. It typically consists of a metal frame containing a lever or pulley-cable system that may incorporate changeable weights and a head pad or head/neck harness; a bench may be included for the user to sit while performing the exercise. The device may also be used to improve neck flexibility and mobility.	Active	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
Handling Environment Atmospheric Pressure: between 55 and 106 KiloPascal
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 55 and 106 KiloPascal
Storage Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5925ab4b-1df1-4958-8b7f-9a928fa5fc71
Public Version Date: May 13, 2020
Public Version Number: 4
DI Record Publish Date: August 25, 2016