Insert, Tapered Right Angle Dissector ES0008

GUDID 10815288011030

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable
Primary Device ID10815288011030
NIH Device Record Key8a1681f0-e186-4bdc-80d7-aafc780ed6b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsert, Tapered Right Angle Dissector
Version Model NumberES0008
Catalog NumberES0008
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
GS110815288011030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10815288011030]

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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10815288011795 - 5mm Cobra Jaw Grasping Forcep, Ratcheting Handle, With Rotation2024-02-08
10815288013799 - Fenestrating Grasping Forcep, 35cm2024-02-08 Fenestrating Grasping Forcep, 35cm with Rotating/Ratcheting Handle
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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