Sterishot (Femcare) for Minilaparotomy AVM-600M

GUDID 15055515602340

Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Minilap Applicator ONLY as part of a kit.

FEMCARE LIMITED

Fallopian tube clip/band

• Primary Device ID: 15055515602340
• NIH Device Record Key: 0caa6e5b-4264-4ada-86ed-0f8323fae572
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterishot (Femcare) for Minilaparotomy
• Version Model Number: AVM-600M
• Catalog Number: AVM-600M
• Company DUNS: 500218573
• Company Name: FEMCARE LIMITED
• 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: 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
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	15055515602340 [Primary]

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: 2023-05-23
• Device Publish Date: 2023-05-15

Devices Manufactured by FEMCARE LIMITED

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• 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.