AccessGUDID - DEVICE: Rochester (10816843020061)

GUDID

Device Identifier (DI) Information

Brand Name: Rochester
Version or Model: 035689
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ROCHESTER ELECTRO-MEDICAL, INC.

Primary DI Number: 10816843020061
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 068156330 *Terms of Use

Device Description: REUSABLE GROUND ELECTRODES: 1.25" DIAMETER, STAINLESS STEEL GROUNDS, GREEN, 4 FT (1.2 M), HEAVY-DUTY WIRE

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):	Yes
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?
35750	Analytical non-scalp cutaneous lead	An insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG) and is not a dedicated neuromuscular transmission (NMT) lead set. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous

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: f0805e6e-91a9-4d38-85c6-8f4f8febc70a
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016