Rounded Maryland Dissector ES0586

GUDID 10815288014253

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable

Primary Device ID	10815288014253
NIH Device Record Key	95ff6221-d3be-4d0e-8b96-39c82ecd4b29
Commercial Distribution Status	In Commercial Distribution
Brand Name	Rounded Maryland Dissector
Version Model Number	ES0586
Catalog Number	ES0586
Company DUNS	612250175
Company Name	ENCISION, INC.
Device Count	1
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter
Length	35 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288014253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191612

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories