Insert, Tapered Micro-Fenestrated Grasper ES0558

GUDID 10815288012136

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable
Primary Device ID10815288012136
NIH Device Record Keyd79a36d9-e4b7-4887-83bd-f2da8774e0b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsert, Tapered Micro-Fenestrated Grasper
Version Model NumberES0558
Catalog NumberES0558
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 Identifiers

Device Issuing AgencyDevice ID
GS110815288012136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10815288012136]

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

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