PTFE coated cannula Ø 5 mm, 450 mm for irrigation/suction system, single use

GUDID E296OMSFLA051

AB MEDICA

Laparoscopic irrigation/aspiration cannula

• Primary Device ID: E296OMSFLA051
• NIH Device Record Key: 22fed5ff-52ee-4624-b87c-89bc6e8c9226
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTFE coated cannula Ø 5 mm, 450 mm for irrigation/suction system, single use
• Version Model Number: OMS/FLA05
• Company DUNS: 260445203
• Company Name: AB MEDICA
• Device Count: 4
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E296OMSFLA050 [Unit of Use]
HIBCC	E296OMSFLA051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151822

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-12-10
• Device Publish Date: 2018-07-23

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• E496COEC350750 - REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=75MM: 2021-08-02
• E496COEC351000 - REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=100MM: 2021-08-02
• E496LILIP2SC20ST0 - Low Impact™ Curved Scissors, Jaw Insert (sterile) L=20cm: 2021-06-21
• E496C35IP2AL330 - C35-Allis Grasping Forceps, 2 mobile jaws Insert L=33mm D=3,5mm: 2021-04-09
• E496C35IP2BI330 - C35-Biopsy 2 mobile jaws insert L 33cm D 3,5mm: 2021-04-09