Filshie® Clips AVM-851

GUDID 05055515602121

The Filshie Tubal Ligation System or Filshie Clip system is a contraceptive tubal occlusion device indicated for permanent female sterilization by occ

FEMCARE LIMITED

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• Primary Device ID: 05055515602121
• NIH Device Record Key: 6c8dd9f4-a8aa-4bf1-abb0-2551b0b16b76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Filshie® Clips
• Version Model Number: Twenty pair sterile Filshie Clips
• Catalog Number: AVM-851
• Company DUNS: 500218573
• Company Name: FEMCARE LIMITED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055515602121 [Primary]
GS1	15055515602128 [Package]; Package: Printed Card Carton [20 Units]; In Commercial Distribution
GS1	15055515602234 [Primary]
GS1	25055515602125 [Package]; Contains: 15055515602128; Package: Card Container [10 Units]; In Commercial Distribution
GS1	35055515602238 [Package]; Contains: 15055515602234; Package: Carton [20 Units]; In Commercial Distribution
GS1	55055515602232 [Package]; Contains: 35055515602238; Package: Overpack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P920046

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: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2014-09-25

On-Brand Devices [Filshie® Clips]

• 05055515602121: The Filshie Tubal Ligation System or Filshie Clip system is a contraceptive tubal occlusion devi
• 05055515602114: The Filshie Tubal Ligation System or Filshie Clip system is a contraceptive tubal occlusion devi
• 05055515602268: The Filshie Tubal Ligation System - Filshie Clips for permanent female sterilization by occlusio