USA Elite System™ Rotating Continuous Flow Resectoscope Visual Obtura

GUDID 00821925003170

ERVO-CF27 VISUAL OBTURATOR CF ROT 27FR

Gyrus Acmi, Inc.

Resectoscope
Primary Device ID00821925003170
NIH Device Record Keyc4416dec-d6b5-4c52-a7ba-f318cbe09d63
Commercial Distribution StatusIn Commercial Distribution
Brand NameUSA Elite System™ Rotating Continuous Flow Resectoscope Visual Obtura
Version Model NumberERVO-CF27
Company DUNS007198742
Company NameGyrus Acmi, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Identifiers

Device Issuing AgencyDevice ID
GS100821925003170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FECOBTURATOR, FOR ENDOSCOPE
HIHHysteroscope (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


[00821925003170]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-14

On-Brand Devices [USA Elite System™ Rotating Continuous Flow Resectoscope Visual Obtura]

00821925003170ERVO-CF27 VISUAL OBTURATOR CF ROT 27FR
00821925003163ERVO-CF25 OBTURATOR ROT CF 25FR

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