OPER CHOLANGIOGRAPHY CATHETER

Basic Information

• Brand Name: OPER CHOLANGIOGRAPHY CATHETER
• Primary DI: 00858690006310
• Version / Model: 18 GAUGE X 7"
• Catalog Number: ORC-B
• Company Name: RANFAC CORP.
• Labeler DUNS: 121622872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 193177e3-b993-40a8-9c36-8f7a4da3a1e9

Device Description

OPER CHOLANGIOGRAPHY CATHETER ORC TYPE B PN 68010-01M

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
GBZ	Catheter, Cholangiography	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41976	Rigid endoscopic cannula, single-use	A sterile, rigid, single-lumen device intended to be used during endoscopy to provide cannulation for the instillation or aspiration of fluid to/from a targeted area of the body (e.g., introduction of drug solutions, a contrast medium or other kinds of fluid/solution into a body cavity for diagnosis and treatment) or for the introduction/accommodation of another device. It will typically be made of high-grade stainless steel and/or other durable materials. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20858690006314	GS1	Case	8	In Commercial Distribution
Package	10858690006317	GS1	Inner Pack	10	In Commercial Distribution
Primary	00858690006310	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			18 GAUGE x 7"