CER-SUB-825

Basic Information

• Brand Name: CER-SUB-825
• Primary DI: 00850023741141
• Version / Model: 8GA X 25CM
• Catalog Number: 74375-01M
• Company Name: RANFAC CORP.
• Labeler DUNS: 121622872
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-19
• Public Version: 1
• Public Version Date: 2021-05-27
• Public Version Status: New
• Public Device Record Key: 0a221fac-30d2-4eee-9390-bc27631e17a5

Device Description

Cervos 8GA Subchondral Needle P/N: 74375-01M Customer #: 12153

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
FGY	Cannula, Injection	General, Plastic Surgery	878.4200	1

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
Primary	00850023741141	GS1
Package	10850023741148	GS1	Inner Pack	1	In Commercial Distribution
Package	20850023741145	GS1	Case	30	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	25	Centimeter
Needle Gauge	8	Gauge