Filshie® Clips (Femcare) AVM-851J

GUDID 05055515602244

The Filshie Tubal Ligation System - Filshie Clips for permanent female sterilization by occlusion of the Fallopian tubes.

FEMCARE LIMITED

Fallopian tube clip/band

• Primary Device ID: 05055515602244
• NIH Device Record Key: fe9ad19d-be21-4f8e-a1c8-455f52ce5250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Filshie® Clips (Femcare)
• Version Model Number: AVM-851J
• Catalog Number: AVM-851J
• Company DUNS: 500218573
• Company Name: FEMCARE LIMITED
• Device Count: 2
• 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: true
• 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

Customer Support Contacts

• Phone: +441794525100
• Email: enquiries@femcare.co.uk
• Phone: +441794525100
• Email: enquiries@femcare.co.uk
• Phone: +441794525100
• Email: enquiries@femcare.co.uk
• Phone: +441794525100
• Email: enquiries@femcare.co.uk
• Phone: +441794525100
• Email: enquiries@femcare.co.uk
• Phone: +441794525100
• Email: enquiries@femcare.co.uk

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055515602244 [Unit of Use]
GS1	25055515602248 [Primary]
GS1	45055515602242 [Package]; Contains: 25055515602248; Package: Box [10 Units]; In Commercial Distribution
GS1	65055515602246 [Package]; Contains: 45055515602242; Package: Overpack [20 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-10
• Device Publish Date: 2025-02-28

Devices Manufactured by FEMCARE LIMITED

• 05055515602244 - Filshie® Clips (Femcare): 2025-03-10The Filshie Tubal Ligation System - Filshie Clips for permanent female sterilization by occlusion of the Fallopian tubes.
• 05055515602244 - Filshie® Clips (Femcare): 2025-03-10 The Filshie Tubal Ligation System - Filshie Clips for permanent female sterilization by occlusion of the Fallopian tubes.
• 15055515600261 - No-Scalpel Vasectomy: 2023-06-15 No-Scalpel Vasectomy Ring Clamp, 3.5mm
• 15055515600278 - No-Scalpel Vasectomy: 2023-06-15 No-Scalpel Vasectomy 3.5mm kit
• 15055515600285 - No-Scalpel Vasectomy: 2023-06-15 No-Scalpel Vasectomy Forcep
• 15055515600292 - No-Scalpel Vasectomy: 2023-06-15 No-Scalpel Vasectomy 4.0mm kit
• 15055515600308 - No-Scalpel Vasectomy: 2023-06-15 No-Scalpel Vasectomy Ring Clamp, 4.0mm
• 05055515602268 - Filshie® Clips: 2023-05-23 The Filshie Tubal Ligation System - Filshie Clips for permanent female sterilization by occlusion of the Fallopian tubes. Single
• 15055515602326 - Sterishot: 2023-05-23 Single Patient Use Filshie® Clip Applicator System. Applicator for use ONLY in Sterishot Kits.