Irrigation/suction gravity system w/o cannula

Basic Information

• Brand Name: Irrigation/suction gravity system w/o cannula
• Primary DI: E296OMSFLA02GESC1
• Version / Model: OMS/FLA02-GE-SC
• Company Name: AB MEDICA
• Labeler DUNS: 260445203
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2018-07-23
• Public Version: 2
• Public Version Date: 2018-12-10
• Public Version Status: Update
• Public Device Record Key: 22981065-7b68-4ab3-8880-8d82cd2c2510

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
47342	Laparoscopic irrigation/aspiration cannula	A rigid, sterile, hand-operated, tube-like device intended to be inserted through a laparoscopic port to provide a conduit for the instillation and/or aspiration of fluid during laparoscopy. It has a single-lumen, a proximal handle, and is typically made of plastic materials. It is connected via tubing to an appropriate irrigating/aspirating device(s), the irrigation/aspiration being regulated by the operator with mechanical valve controls typically in the handle of the cannula. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E296OMSFLA02GESC1	HIBCC
Unit of Use	E296OMSFLA02GESC0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K151822	000