EasyShears micro reusable ESM1010

GUDID EAMIESM10100

AMI Agency for Medical Innovations GmbH

Endoscopic electrosurgical electrode, monopolar, reusable
Primary Device IDEAMIESM10100
NIH Device Record Keya8aa311b-0554-4161-ae0e-3676d96400c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasyShears micro reusable
Version Model NumberESM1010
Catalog NumberESM1010
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 Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter
Length21 Millimeter
Outer Diameter3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEAMIESM10100 [Primary]
HIBCCEAMIESM10101 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

Moist Heat or Steam Sterilization


[EAMIESM10100]

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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