Insert, Wave Grasper ES0537

GUDID 10815288011733

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable
Primary Device ID10815288011733
NIH Device Record Keyf2259d70-9009-4753-b954-08e382a919a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsert, Wave Grasper
Version Model NumberES0537
Catalog NumberES0537
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110815288011733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10815288011733]

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 [Insert, Wave Grasper]

10815288011740ES0537-45
10815288011733ES0537

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