Insert, Fenestrated Bowel Grasper ES0574

GUDID 10815288013256

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable
Primary Device ID10815288013256
NIH Device Record Key5166ae20-89e6-46b5-9210-e5c7bf24c3d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsert, Fenestrated Bowel Grasper
Version Model NumberES0574
Catalog NumberES0574
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
GS110815288013256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10815288013256]

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, Fenestrated Bowel Grasper]

10815288013294ES0574-45
10815288013256ES0574
10815288011481ES0522-45
10815288011474ES0522

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