Disposable valve for trocar D=3,5mm C35-SEAL-1

GUDID E496C35SEAL10

AB MEDICA

Laparoscopic access cannula seal, single-use

• Primary Device ID: E496C35SEAL10
• NIH Device Record Key: 49811160-4665-4dbd-ad8f-fb9d08f4a7b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable valve for trocar D=3,5mm
• Version Model Number: C35-SEAL-1
• Catalog Number: C35-SEAL-1
• Company DUNS: 260445203
• Company Name: AB MEDICA
• Device Count: 25
• 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	E496C35SEAL10 [Unit of Use]
HIBCC	E496C35SEAL11 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140101

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-11
• Device Publish Date: 2020-03-03

Devices Manufactured by AB MEDICA

• E496C35HH330 - C35-Hand Activated HOOK L=330mm: 2021-08-02
• E496COEC3501200 - REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=120MM: 2021-08-02
• E496COEC350600 - REUSABLE CANNULA TROCAR WITH LOCK TAP D=3.5MM L=60MM: 2021-08-02
• 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