Disposable Falope-Ring® Band Applicator Kit

GUDID 00821925032989

Gyrus Acmi, Inc.

Fallopian tube clip/band

• Primary Device ID: 00821925032989
• NIH Device Record Key: c708b6c5-fa48-4296-9882-c95a5fb57135
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Falope-Ring® Band Applicator Kit
• Version Model Number: 006889-901
• 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: true
• 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

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925000360 [Package]; Package: [8 Units]; In Commercial Distribution
GS1	00821925032989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P870076

FDA Product Code

• KNH: Device, Occlusion, Tubal, Contraceptive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-19

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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