M3 Gold Autoclavable Foroblique Telescope 30°, Color Coded White

GUDID 00821925005679

M3-30A M3-GOLD AUTOCLAVABLE TEL 30 DEG

Gyrus Acmi, Inc.

Rigid endoscope telescope
Primary Device ID00821925005679
NIH Device Record Keycaf88065-f347-48e4-8eda-708bab93fcf7
Commercial Distribution StatusIn Commercial Distribution
Brand NameM3 Gold Autoclavable Foroblique Telescope 30°, Color Coded White
Version Model NumberM3-30A
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
GS100821925005679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


[00821925005679]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-14

Devices Manufactured by Gyrus Acmi, Inc.

00821925043916 - SOLTIVE2024-08-09 SOLTIVE SuperPulsed Laser Fiber 150 Micron
00821925043930 - SOLTIVE2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
00821925043978 - SOLTIVE2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
00821925043992 - SOLTIVE2024-08-09 SOLTIVE SuperPulsed Laser Fiber 365 Micron
00821925044074 - SOLTIVE2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron
00821925002074 - USA Elite System2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002098 - USA Elite System2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002111 - USA Elite System2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold

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