AEM® Handle, Hooded ES8000H

GUDID 10815288010255

ENCISION, INC.

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Primary Device ID	10815288010255
NIH Device Record Key	2bf3c9cd-bb75-4158-95d9-be0b182af1ff
Commercial Distribution Status	In Commercial Distribution
Brand Name	AEM® Handle, Hooded
Version Model Number	ES8000H
Catalog Number	ES8000H
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
Length	35 Centimeter
Length	35 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288010255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191612

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories