NRG Transseptal Needle

Basic Information

• Brand Name: NRG Transseptal Needle
• Primary DI: 00685447004585
• Version / Model: NRG-E-56-32-C0
• Company Name: Baylis Médicale Cie Inc
• Labeler DUNS: 249225954
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-10
• Public Version: 4
• Public Version Date: 2023-12-08
• Public Version Status: Update
• Public Device Record Key: 7f975734-b1ab-4feb-ac40-07477e5ebb5b
• Distribution End Date: 2023-02-05

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: 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
DXF	Catheter, Septostomy	Cardiovascular	870.5175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00685447004585	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Proximal OD = 19Ga, Distal OD = 22Ga, Standard Curve C0, Compatible with 0.032" Transseptal Dilator
Length	56	Centimeter