USA Series™ Long Autoclavable Operative Telescope 12°, 2.7mm Diameter

GUDID 00821925008410

Gyrus Acmi, Inc.

Rigid endoscope telescope
Primary Device ID00821925008410
NIH Device Record Key32d90d8d-c03e-4f9f-bedf-f969137962e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameUSA Series™ Long Autoclavable Operative Telescope 12°, 2.7mm Diameter
Version Model NumberREXG27L-12A
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
GS100821925008410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIHHysteroscope (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


[00821925008410]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-05

On-Brand Devices [USA Series™ Long Autoclavable Operative Telescope 12°, 2.7mm Diameter]

00821925008915G27L-12A SlimLine Long Tele 12Deg 2.7MM
00821925008410REXG27L-12A

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