EasyAct Handle EAH1010

GUDID EAMIEAH10100

AMI Agency for Medical Innovations GmbH

Electrosurgical handpiece, reusable

Primary Device ID	EAMIEAH10100
NIH Device Record Key	01b24766-1175-41b8-94a5-453d88f041c8
Commercial Distribution Status	In Commercial Distribution
Brand Name	EasyAct Handle
Version Model Number	EAH1010
Catalog Number	EAH1010
Company DUNS	303655286
Company Name	AMI Agency for Medical Innovations GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EAMIEAH10100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182013

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

[EAMIEAH10100]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-04-15
Device Publish Date	2019-04-05

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