NA

Basic Information

• Brand Name: NA
• Primary DI: 00721902015946
• Version / Model: EP003997S
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-23
• Public Version: 4
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: 03e49aa7-04e3-47b5-b159-57aa21632d6d
• Distribution End Date: 2018-06-21

Device Description

NEEDLE EP003997S BROCKEN 56CM STER 10L

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRC	Trocar	Cardiovascular	870.1390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47248	Cardiac transseptal needle, single-use	A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00721902015946	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	56.0	Centimeter
Outer Diameter	0.912	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -34 – 57 Degrees Celsius