Disposable valves for trocar Ø 3 mm

GUDID E296LILSEAL11

AB MEDICA

Laparoscopic access cannula seal, single-use

• Primary Device ID: E296LILSEAL11
• NIH Device Record Key: 16f0d17c-5675-4175-8642-093a8ab589b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable valves for trocar Ø 3 mm
• Version Model Number: LIL-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	E296LILSEAL10 [Unit of Use]
HIBCC	E296LILSEAL11 [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: 2018-08-13
• Device Publish Date: 2018-07-13

On-Brand Devices [Disposable valves for trocar Ø 3 mm]

• E296LILSEAL31: LIL-SEAL-3
• E296LILSEAL11: LIL-SEAL-1