Laparofan

Basic Information

• Brand Name: Laparofan
• Primary DI: 10884521067899
• Version / Model: OMSLF10
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-03-02
• Public Version Status: Update
• Public Device Record Key: 5f5caeeb-5c3c-4987-87dc-896cfae8e1f8
• Distribution End Date: 2016-09-24

Device Description

V-Shaped Retractor

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36302	Laparoscopic mechanical-distention system	An assembly of mechanical devices intended to be used to create a space in the abdominal cavity for laparoscopic procedures by externally lifting the abdominal wall. This isobaric method of lifting the abdominal wall includes the insertion of a retractor, sling, subcutaneous wires or needles and an external lifting mechanism consisting of, e.g., a manual traction device, a support arm clamped to the operating table, or a winch and framework. This device requires no, or minimal, gas insufflation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521067896	GS1	CASE	5	Not in Commercial Distribution	2016-09-24
Primary	10884521067899	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	10	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 130 Degrees Fahrenheit