AccessGUDID - DEVICE: B&L Engineering Active EMG Surface Electrode (00855144007046)

GUDID

Device Identifier (DI) Information

Brand Name: B&L Engineering Active EMG Surface Electrode
Version or Model: BL-AE-N/NG
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PINSCO, INC.

Primary DI Number: 00855144007046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079605952 *Terms of Use

Device Description: Active EMG Surface Electrode Narrow Spaced - No Ground

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):	Yes
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?
36728	Electromyographic signal amplifier	An electronic device used with an electromyograph (EMG) to increase voltage, current, or power. This GMDN code may reflect old technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKN	Electromyograph, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K952655	000

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: 7f23bb3a-033f-4b70-97bb-6880e2d6f4ed
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 02, 2017