AEM® Handle ES8000

GUDID 10815288010231

ENCISION, INC.

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Primary Device ID	10815288010231
NIH Device Record Key	4064864e-f443-4828-9000-9107424e0f78
Commercial Distribution Status	In Commercial Distribution
Brand Name	AEM® Handle
Version Model Number	ES8000
Catalog Number	ES8000
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	10815288010231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191612

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories