Maxx Cell

Basic Information

• Brand Name: Maxx Cell
• Primary DI: 00857878007453
• Version / Model: 11GA X 11CM
• Catalog Number: MXC-2
• Company Name: RANFAC CORP.
• Labeler DUNS: 121622872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-13
• Public Version: 1
• Public Version Date: 2018-09-13
• Public Version Status: New
• Public Device Record Key: 26d5d1a5-bed1-431f-a868-4418c1664b0f

Device Description

MC-RAN-11CSTS MAXX CELL WITH PREPARATION ACCESSORIES PN 74317-02M Customer# 0018407

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
16833	Bone marrow biopsy procedure kit	A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857878007453	GS1
Package	10857878007450	GS1	Inner	1	In Commercial Distribution
Package	20857878007457	GS1	Case	15	In Commercial Distribution

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