AccessGUDID - DEVICE: Rochester (10816843021303)

GUDID

Device Identifier (DI) Information

Brand Name: Rochester
Version or Model: S0152015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ROCHESTER ELECTRO-MEDICAL, INC.

Primary DI Number: 10816843021303
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2019
Device Count: 2
Labeler D-U-N-S® Number*: 068156330 *Terms of Use

Device Description: NASOPHARYNGEAL ELECTRODES: SILVER BALL ELECTRODE, 6 FT. (1.8 M), SINGLE, SILICONE 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?
11452	Nasopharyngeal electrode	An electrical conductor intended to be temporarily placed in the nasopharyngeal region to record electrical activity. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZK	Electrode, Nasopharyngeal

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: 9ed09ed1-3129-42c2-bd8f-d165082d39a8
Public Version Date: May 21, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016