Lapcap2 LC2-STD

GUDID 05060484670002

A sterile, singe use, acrylic dome shaped device with a port for attachment of the suction system and septum for the insertion of a Veress needle. It

LIFE CARE MEDICAL DEVICES LIMITED

Laparoscopic access suction dome

• Primary Device ID: 05060484670002
• NIH Device Record Key: c1406ff5-3f87-47d8-b33e-ed68b86c6c99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lapcap2
• Version Model Number: LC2-STD
• Catalog Number: LC2-STD
• Company DUNS: 220683901
• Company Name: LIFE CARE MEDICAL DEVICES 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: 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

• Phone: +441273704527
• Email: customerservice@lifecaredevice

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060484670002 [Primary]
GS1	15060484670009 [Package]; Package: Corrugated Cardboard [10 Units]; In Commercial Distribution
GS1	25060484670006 [Package]; Contains: 15060484670009; Package: Glued Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070651

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

[05060484670002]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-04
• Device Publish Date: 2016-06-08