USA Elite System™ Rotating Continuous Flow Resectoscope Inner Sheath

GUDID 00821925011014

Gyrus Acmi, Inc.

Resectoscope

• Primary Device ID: 00821925011014
• NIH Device Record Key: bc298824-2d13-47b6-8cca-d9561228edb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite System™ Rotating Continuous Flow Resectoscope Inner Sheath
• Version Model Number: REXERIS-CF25
• 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	00821925011014 [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

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

Moist Heat or Steam Sterilization

[00821925011014]

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: 2016-10-05

On-Brand Devices [USA Elite System™ Rotating Continuous Flow Resectoscope Inner Sheath]

• 00821925011014: REXERIS-CF25
• 00821925008298: REXERIS-CF27