AUTOCLAVABLE ROD LENS LARYNGOSCOPE

GUDID 00821925030756

Gyrus Acmi, Inc.

Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope Rigid optical laryngopharyngoscope
Primary Device ID00821925030756
NIH Device Record Keyd58288f6-0d66-492a-9980-5c2ab8799962
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTOCLAVABLE ROD LENS LARYNGOSCOPE
Version Model Number70230906
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925030756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBRONCHOSCOPE (FLEXIBLE OR RIGID)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


[00821925030756]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-03

Devices Manufactured by Gyrus Acmi, Inc.

00810008180983 - nCare2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG
00810008180990 - nCare2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
00810008180501 - nCare2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
00810008180921 - nCare2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
00810008180952 - nCare2023-09-25 nCare, SNGL,DRCT SDI,DICOM
00810008180969 - nCare2023-09-25 nCare, SNGL, ELA, DICOM
00810008180976 - nCare2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
00821925036406 - USA Elite2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.