USA Elite System™ McCarthy™ Working Element

GUDID 00821925008281

Gyrus Acmi, Inc.

Resectoscope

• Primary Device ID: 00821925008281
• NIH Device Record Key: 9325791d-51e2-45c4-bc2c-c9f338bda07a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite System™ McCarthy™ Working Element
• Version Model Number: REXEMWE
• 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	00821925008281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890328

FDA Product Code

• FAS: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

Moist Heat or Steam Sterilization

[00821925008281]

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: 2016-10-05

On-Brand Devices [USA Elite System™ McCarthy™ Working Element]

• 00821925008281: REXEMWE
• 00821925002739: EMWE MONO McCarthy Working Element