Carrera Loop Electrodes

GUDID GYNXOCMR15121

Electrocautery system electrode

Primary Device ID	GYNXOCMR15121
NIH Device Record Key	20195e2a-55f9-4022-870f-cb348e556e7c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Carrera Loop Electrodes
Version Model Number	OCMR-1512
Company DUNS	012997685
Company Name	GYNEX CORPORATION
Device Count	5
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	GYNXOCMR15120 [Unit of Use]
HIBCC	GYNXOCMR15121 [Primary]

HGI	Electrocautery, Gynecologic (And Accessories)

Steralize Prior To Use	false
Device Is Sterile	true