SafeSept Transseptal Guidwire

Basic Information

• Brand Name: SafeSept Transseptal Guidwire
• Primary DI: 00858769006104
• Version / Model: SS-135
• Catalog Number: SS-135
• Company Name: PPMDM
• Labeler DUNS: 081047841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-02
• Public Version: 3
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: 04aaf13f-d6c8-4581-aa52-2c2645b1cf90

Device Description

0.014" Transseptal guidewire.

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: Yes
• 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
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
Package	30858769006105	GS1	Box	5	In Commercial Distribution
Primary	00858769006104	GS1

Premarket Submissions

Submission Number	Supplement Number
K170671	000