KEYPORT

Basic Information

• Brand Name: KEYPORT
• Primary DI: 04055207011355
• Version / Model: 885020
• Catalog Number: 885020
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2023-05-24
• Public Version Status: Update
• Public Device Record Key: 7c23cacc-28c5-445d-a119-a67d77a08c23
• Distribution End Date: 2020-05-24

Device Description

TROCAR SLEEVE SINGLE PORT 31MM plastic sleeve with thread anchoring, wl 30mm, triangular shape, interface for mounting arm (EndoMotion mounting arm 37500.001 and U-shaped mounting arm 8840.9721) and fixation possible to fascia suture interface for silicone sealing insert, reusable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OTJ	Laparoscopic single port access device	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62452	Laparoscopic multi-instrument access port, reusable	A multi-lumen sleeve assembly intended to retract a small abdominal incision to allow multiple laparoscopic instruments to access the abdominal cavity simultaneously through a single abdominal incision, during minimally-invasive laparoscopic surgery. It will include a valve component for each lumen that maintains the established pneumoperitoneum; the trocar used to create the abdominal incision might be included; it may include attached external instrument holding arms. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207011355	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]