Lapcap2

Basic Information

• Brand Name: Lapcap2
• Primary DI: 05060484670002
• Version / Model: LC2-STD
• Catalog Number: LC2-STD
• Company Name: LIFE CARE MEDICAL DEVICES LIMITED
• Labeler DUNS: 220683901
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-08
• Public Version: 4
• Public Version Date: 2019-03-04
• Public Version Status: Update
• Public Device Record Key: c1406ff5-3f87-47d8-b33e-ed68b86c6c99

Device Description

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 assists in the blind passage of a 14G Veress needle to establish a pneumoperitoneum prior to laparoscopic procedures. The device is centered over the umbilicus, a suction hose is attached to the suction port and negative pressure applied. The abdomen rises, allowing the Veress needle to be inserted into the created space. Inert gas is delivered to replace the negative pressure.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	884.1730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61851	Laparoscopic access suction dome	A sterile dome-shaped device intended to facilitate laparoscopic-insufflation needle insertion by causing the anterior abdominal wall to separate from the underlying viscera using vacuum applied to the surface of the abdomen, thereby creating a space for the needle tip. It is typically made of synthetic polymer materials and is designed to be used with the hospital central vacuum system. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060484670002	GS1
Package	15060484670009	GS1	Corrugated Cardboard	10	In Commercial Distribution
Package	25060484670006	GS1	Glued Carton	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K070651	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Standard Size