A.M.I. EasyShear Mini Reusable Tips Premium ESI1140

GUDID EAMIESI11400

AMI Agency for Medical Innovations GmbH

Endoscopic electrosurgical electrode, monopolar, reusable
Primary Device IDEAMIESI11400
NIH Device Record Key1f87c115-1e16-429a-94a1-2f4e0c71b1b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameA.M.I. EasyShear Mini Reusable Tips Premium
Version Model NumberESI1140
Catalog NumberESI1140
Company DUNS303655286
Company NameAMI Agency for Medical Innovations GmbH
Device Count5
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

Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter
Length33 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEAMIESI11400 [Primary]
HIBCCEAMIESI11401 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


[EAMIESI11400]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-15
Device Publish Date2019-04-05

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