AccessGUDID - DEVICE: MJM THERAPY REAHB WEIGHTED BAR (00849229006307)

GUDID

Device Identifier (DI) Information

Brand Name: MJM THERAPY REAHB WEIGHTED BAR
Version or Model: TRWB-L-48
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M J M International Corporation

Primary DI Number: 00849229006307
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 159688993 *Terms of Use

Device Description: THERAPY REHAB WEIGHTED BAR, LILAC 8.5 LBS, 48" LENGTH

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?
31928	Hand-held free weight exerciser	A piece of exercise equipment designed primarily to increase muscle strength especially of the upper body by repetitive lifting and lowering with the hands and arms. It may be one of several types of hand-held weights or masses that are not attached to another structural device, including barbells, dumbbells, kettlebells, weight bars, weight plates, and medicine balls. The device is intended to improve strength especially in the arms, wrists, shoulders, chest, and back; it may also be used to help improve lower-body muscle strength and improve body metabolic rate, balance, flexibility, mobility, and bone density.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOE	Bars, Parallel, Exercise

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1e2a8309-8792-4dc0-abc2-9761009888cf
Public Version Date: March 21, 2025
Public Version Number: 2
DI Record Publish Date: July 31, 2023