CELLXTRACT Autologous Cell and Bone Marrow Extraction

Basic Information

• Brand Name: CELLXTRACT Autologous Cell and Bone Marrow Extraction
• Primary DI: M979CXT1145S0
• Version / Model: CXT1145S 11GA X 11CM
• Catalog Number: CXT1145S
• Company Name: RANFAC CORP.
• Labeler DUNS: 121622872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-27
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: f8695c32-814e-40e1-9a74-04816e1bc448

Device Description

CELLXTRACT Autologous Cell and Bone Marrow Extraction CXT1145S 11GA X 11CM C#0002262 P/N 74271-02M

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	M979CXT1145S9	HIBCC	Case	30	In Commercial Distribution
Package	M979CXT1145S1	HIBCC	Inner Pack	1	In Commercial Distribution
Primary	M979CXT1145S0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150563	000

Device Sizes

Type	Value	Unit	Text
Length	11	Centimeter
Needle Gauge	11	Gauge