USA Elite System™ Accessory Working Element

GUDID 00821925008168

Gyrus Acmi, Inc.

Resectoscope

Primary Device ID	00821925008168
NIH Device Record Key	8b5e6005-0d7d-4c08-8349-5efbd4ba5bdb
Commercial Distribution Status	In Commercial Distribution
Brand Name	USA Elite System™ Accessory Working Element
Version Model Number	REXEAWE
Company DUNS	007198742
Company Name	Gyrus Acmi, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	00821925008168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K890328

FDA Product Code

FEC	OBTURATOR, FOR ENDOSCOPE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

[00821925008168]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2017-05-11

Devices Manufactured by Gyrus Acmi, Inc.

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00821925043930 - SOLTIVE	2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
00821925043978 - SOLTIVE	2024-08-09 SOLTIVE SuperPulsed Laser Fiber 200 Micron
00821925043992 - SOLTIVE	2024-08-09 SOLTIVE SuperPulsed Laser Fiber 365 Micron
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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