Elite 2 System™ Rotating Continuous Flow Resectoscope Timberlake Obtu

GUDID 00821925001657

E2RTO-CF25 Elite 2 Rot CF Timber Obt 25F

Gyrus Acmi, Inc.

Resectoscope

• Primary Device ID: 00821925001657
• NIH Device Record Key: b88ea5b4-9544-4167-9b1d-1f7344c07d13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite 2 System™ Rotating Continuous Flow Resectoscope Timberlake Obtu
• Version Model Number: E2RTO-CF25
• 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	00821925001657 [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

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

Moist Heat or Steam Sterilization

[00821925001657]

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: 2016-10-13

On-Brand Devices [Elite 2 System™ Rotating Continuous Flow Resectoscope Timberlake Obtu]

• 00821925001664: E2RTO-CF27 Elite2 OBT TIMBER CF ROT 27FR
• 00821925001657: E2RTO-CF25 Elite 2 Rot CF Timber Obt 25F