AEM® Handle Hooded ES8200H

GUDID 10815288010293

ENCISION, INC.

Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable
Primary Device ID10815288010293
NIH Device Record Key7171baf6-ebc6-4fcd-97f3-dd8f9627e23d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAEM® Handle Hooded
Version Model NumberES8200H
Catalog NumberES8200H
Company DUNS612250175
Company NameENCISION, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Length35 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110815288010293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


[10815288010293]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-25
Device Publish Date2016-08-31

On-Brand Devices [AEM® Handle Hooded]

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10815288010293ES8200H
10815288010262ES8000HL

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