Disposable valve for trocar D=3,5mm

Basic Information

• Brand Name: Disposable valve for trocar D=3,5mm
• Primary DI: E496C35SEAL11
• Version / Model: C35-SEAL-1
• Catalog Number: C35-SEAL-1
• Company Name: AB MEDICA
• Labeler DUNS: 260445203
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-03-03
• Public Version: 1
• Public Version Date: 2020-03-11
• Public Version Status: New
• Public Device Record Key: 49811160-4665-4dbd-ad8f-fb9d08f4a7b0

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
45645	Laparoscopic access cannula seal, single-use	A small, sterile device intended to create a seal between a laparoscopic access cannula (not included) and an appropriately sized laparoscopic instrument, to inhibit the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to be fitted directly to the proximal end of the sleeve and is typically available in a variety of sizes appropriate for given sleeve/instrument diameters. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	E496C35SEAL10	HIBCC
Primary	E496C35SEAL11	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K140101	000