Andrew Babcock Forcep, 45cm, 19mm Jaw, Ratcheting Handle with Rotation EP3770-45RR

GUDID 10815288014048

ENCISION, INC.

Rigid endoscopic tissue manipulation forceps, reusable
Primary Device ID10815288014048
NIH Device Record Key3fecdc68-1886-4760-a05b-59ef4bb49ac4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAndrew Babcock Forcep, 45cm, 19mm Jaw, Ratcheting Handle with Rotation
Version Model NumberEP3770-45RR
Catalog NumberEP3770-45RR
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter
Length45 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110815288014048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HETLaparoscope, Gynecologic (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


[10815288014048]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-25
Device Publish Date2020-09-17

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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