Insert, Maryland Dissector, Aggressive ES0549

GUDID 10815288011955

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable
Primary Device ID10815288011955
NIH Device Record Key32abd0e7-b7b7-4dae-9502-b55783da504a
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsert, Maryland Dissector, Aggressive
Version Model NumberES0549
Catalog NumberES0549
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
GS110815288011955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10815288011955]

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

Devices Manufactured by ENCISION, INC.

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10815288013805 - Allis Forcep, 35cm2024-02-08 Allis Forcep, 35cm with Rotating/Ratcheting Handle
10815288013812 - Fenestrated Bowel Grasper, 35cm, 20mm Jaw2024-02-08 Fenestrated Bowel Grasper, 35cm, 20mm Jaw
10815288013829 - Traumatic Grasper, 35cm2024-02-08 Traumatic Grasper, 35cm with Rotating/Ratcheting Handle
10815288014253 - Rounded Maryland Dissector2023-06-29

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