4CM Tungsten Needle Ext Ins; No Coat; 2.75"; Blue Ins; Black Ext Ins-PL

Basic Information

• Brand Name: 4CM Tungsten Needle Ext Ins; No Coat; 2.75"; Blue Ins; Black Ext Ins-PL
• Primary DI: 00787551035346
• Version / Model: 20102SPI
• Catalog Number: 20102SPI
• Company Name: XODUS MEDICAL, INC.
• Labeler DUNS: 868042664
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: a2b52f1f-1a18-4530-9164-bad7aca4b9db

Device Description

4CM Tungsten Needle Ext Ins; No Coat; 2.75"; Blue Ins; Black Ext Ins-PL

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20787551035340	GS1	CASE	200	In Commercial Distribution
Package	10787551035343	GS1	BOX	10	In Commercial Distribution
Primary	00787551035346	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081647	000