Ranfac Aspiration Needle, 11GA X 150mm, RAN-1115N5T

Basic Information

• Brand Name: Ranfac Aspiration Needle, 11GA X 150mm, RAN-1115N5T
• Primary DI: 00858690006358
• Version / Model: 11GA X 150mmN5T
• Catalog Number: RAN-1115N5T
• Company Name: RANFAC CORP.
• Labeler DUNS: 121622872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-09
• Public Version: 4
• Public Version Date: 2019-05-30
• Public Version Status: Update
• Public Device Record Key: 7fabb2c2-5b3b-4233-8790-b4030af0689f

Device Description

Ranfac Aspiration Needle, 11GA X 150mm RAN-1115N5T, Sterile, F/G P/N 74181-15M

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: 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
KNW	Instrument, Biopsy	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60478	Bone access cannula	A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20858690006352	GS1	Case	32	In Commercial Distribution
Package	10858690006355	GS1	Inner Pack	1	In Commercial Distribution
Primary	00858690006358	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131157	000

Device Sizes

Type	Value	Unit	Text
Length	150	Millimeter
Needle Gauge	11	Gauge

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit