GYRUS,WORKING ELEMENT,ACT

GUDID 00821925009257

Gyrus Acmi, Inc.

Resectoscope

• Primary Device ID: 00821925009257
• NIH Device Record Key: 2c2542e2-3ee1-4d42-84ee-0c277d9e9a4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GYRUS,WORKING ELEMENT,ACT
• Version Model Number: 714600
• 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	00821925009257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990628

FDA Product Code

• FDS: Gastroscope and accessories, flexible/rigid

Sterilization

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

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

Moist Heat or Steam Sterilization

[00821925009257]

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: 2016-10-06

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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
• 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