LAP CHOLANGIOGRAPHY CATHETER

Basic Information

• Brand Name: LAP CHOLANGIOGRAPHY CATHETER
• Primary DI: 00858690006945
• Version / Model: 18 GAUGE x 13"
• Catalog Number: LAP-13
• 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: c0936008-26f5-430b-a043-5d88f5ff16d0

Device Description

LAP CHOLANGIOGRAPHY CATHETER LAP-13

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	20858690006949	GS1	Case	12	In Commercial Distribution
Package	10858690006942	GS1	Inner Pack	6	In Commercial Distribution
Primary	00858690006945	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			18 GAUGE x 13"