AEM® Handle Hooded ES8000HL

GUDID 10815288010262

ENCISION, INC.

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Primary Device ID	10815288010262
NIH Device Record Key	e610633d-ea3c-48fb-a244-f3ff850f6c91
Commercial Distribution Status	In Commercial Distribution
Brand Name	AEM® Handle Hooded
Version Model Number	ES8000HL
Catalog Number	ES8000HL
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	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter
Length	45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288010262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191612

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories