10mm Spoon Forcep, Ratcheting Handle, With Rotation EP4240RR

GUDID 10815288013980

ENCISION, INC.

Laparoscopic grasping forceps, reusable
Primary Device ID10815288013980
NIH Device Record Key6b50a5c3-370d-4d23-bdc1-fd4299468ec8
Commercial Distribution StatusIn Commercial Distribution
Brand Name10mm Spoon Forcep, Ratcheting Handle, With Rotation
Version Model NumberEP4240RR
Catalog NumberEP4240RR
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length35 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110815288013980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HETLaparoscope, Gynecologic (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10815288013980]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-17
Device Publish Date2019-07-09

Devices Manufactured by ENCISION, INC.

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10815288013805 - Allis Forcep, 35cm2024-02-08 Allis Forcep, 35cm with Rotating/Ratcheting Handle
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10815288013829 - Traumatic Grasper, 35cm2024-02-08 Traumatic Grasper, 35cm with Rotating/Ratcheting Handle
10815288014253 - Rounded Maryland Dissector2023-06-29

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