AccessGUDID - DEVICE: Richmar (00850030915214)

GUDID

Device Identifier (DI) Information

Brand Name: Richmar
Version or Model: RM-410-010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: South Dakota Partners Inc.

Primary DI Number: 00850030915214
Issuing Agency: GS1
Commercial Distribution End Date: August 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080639793 *Terms of Use

Device Description: Richmar CM2 RM-410-010

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?
66709	Multi-modality electrotherapy system	An assembly of nonimplantable devices intended to apply multiple electrotherapy modalities [e.g., transcutaneous electrical nerve stimulation (TENS), galvanic stimulation, medicinal electrophoresis (iontophoresis), interferential current] to various parts of the body for the treatment of multiple types of conditions (e.g., gynaecological, proctological, dermatological, neurological, dental and ENT). It consists of an electrically-powered control unit/generator and a handpiece with dedicated applicators/probes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief
IPF	Stimulator, Muscle, Powered
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
LIH	Interferential Current Therapy

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: a18e9234-1a3d-428c-adb9-82ec35f1a919
Public Version Date: April 04, 2025
Public Version Number: 3
DI Record Publish Date: August 02, 2023