BILLEAU WAX CURETTE SMALL, DISPOSABLE

GUDID 00821925017498

Gyrus Acmi, Inc.

General-purpose curette

• Primary Device ID: 00821925017498
• NIH Device Record Key: 067053d5-e628-4ba0-b652-6174e0628501
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BILLEAU WAX CURETTE SMALL, DISPOSABLE
• Version Model Number: 130750
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00821925017498 [Package]; Contains: 00821925033351; Package: [6 Units]; In Commercial Distribution
GS1	00821925033351 [Primary]

FDA Product Code

• LRC: INSTRUMENT, ENT MANUAL SURGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-09-10
• Device Publish Date: 2018-09-06

Devices Manufactured by Gyrus Acmi, Inc.

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• 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