USA Elite System™ Standard Flow Resectoscope Visual Obturator 25.6 Fr

GUDID 00821925003682

EVO-CFR-25 VISUAL OBTURATOR CF 25FR

Gyrus Acmi, Inc.

Resectoscope

Primary Device ID	00821925003682
NIH Device Record Key	d41a3dbe-6126-40bc-ba49-761f6fb07104
Commercial Distribution Status	In Commercial Distribution
Brand Name	USA Elite System™ Standard Flow Resectoscope Visual Obturator 25.6 Fr
Version Model Number	EVO-CFR-25
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	00821925003682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K890328

FDA Product Code

FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIH	Hysteroscope (And Accessories)

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

Moist Heat or Steam Sterilization

[00821925003682]

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	2016-10-14

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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
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