ACMI USA Elite System and USA Series Vapor Trode Vaporization Electr

GUDID 00821925008106

Gyrus Acmi, Inc.

Endoscopic electrosurgical electrode, monopolar, single-use
Primary Device ID00821925008106
NIH Device Record Keybe9d6a76-4c51-4307-9d1b-5cee75529676
Commercial Distribution StatusIn Commercial Distribution
Brand NameACMI USA Elite System and USA Series Vapor Trode Vaporization Electr
Version Model NumberVE-F
Company DUNS007198742
Company NameGyrus Acmi, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925008106 [Package]
Contains: 00821925041820
Package: [6 Units]
In Commercial Distribution
GS100821925041820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-06

On-Brand Devices [ACMI USA Elite System and USA Series Vapor Trode Vaporization Electr]

00821925008106VE-F
00821925008090VE-B

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