ONEPORT

Basic Information

• Brand Name: ONEPORT
• Primary DI: 20653405040528
• Version / Model: RBT-12
• Catalog Number: RBT-12
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-06-08
• Public Version Status: Update
• Public Device Record Key: b0746224-13c2-41bb-b0de-a4d79bfe12b8
• Distribution End Date: 2022-06-07

Device Description

Bladed Obturator With Locking Shield And Universal Seal Body

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
44096	Laparoscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20653405040528	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K073009	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit