GYRUS, PLASMA SECT UROLOGY

GUDID 00821925009233

Gyrus Acmi, Inc.

Endoscopic electrosurgical electrode, bipolar, single-use
Primary Device ID00821925009233
NIH Device Record Key84c3d350-0b7d-41c2-a962-c0b5cc017f02
Commercial Distribution StatusIn Commercial Distribution
Brand NameGYRUS, PLASMA SECT UROLOGY
Version Model Number714520
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
GS100821925009233 [Package]
Contains: 00821925039575
Package: [5 Units]
In Commercial Distribution
GS100821925039575 [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 Number5
Public Version Date2019-02-07
Device Publish Date2016-10-06

Devices Manufactured by Gyrus Acmi, Inc.

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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

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