GYRUS ENT G3 FOOTSWITCH 2-PEDAL

GUDID 00821925010864

Gyrus Acmi, Inc.

Electrosurgical system

Primary Device ID	00821925010864
NIH Device Record Key	b714cb39-b1e0-4e08-b20b-ccdbf2c5420d
Commercial Distribution Status	In Commercial Distribution
Brand Name	GYRUS ENT G3 FOOTSWITCH 2-PEDAL
Version Model Number	7035-3002
Company DUNS	007198742
Company Name	Gyrus Acmi, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925010864 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K041285

FDA Product Code

GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00821925010864]

Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

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Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

[00821925010864]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-05-11

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00821925044074 - SOLTIVE	2024-08-09 SOLTIVE SuperPulsed Laser Fiber 940 Micron
00821925002074 - USA Elite System	2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002098 - USA Elite System	2024-08-02 USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
00821925002111 - USA Elite System	2024-08-02 USA Elite System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr, (8.5 mm) Color Coded Gold

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