Stradis Medical, LLC

Basic Information

• Brand Name: Stradis Medical, LLC
• Primary DI: M752TSBRF6640
• Version / Model: TSBRF-664
• Company Name: STRADIS MEDICAL LLC
• Labeler DUNS: 043537671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-26
• Public Version: 1
• Public Version Date: 2020-11-03
• Public Version Status: New
• Public Device Record Key: 2099af2e-da2e-4aec-ae16-e3207a8eb0af

Device Description

TROCAR KIT 4.5MM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
DRC	Trocar	Cardiovascular	870.1390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63148	Pellet implantation cannula	A sterile, rigid tube intended for subcutaneous delivery of an implantable drug pellet. The cannula is typically designed with a proximal well/side-hole for pellet loading, and typically includes a trocar blade to assist cannula introduction and a push rod to drive the pellet down the cannula; the implant is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M752TSBRF6645	HIBCC	outer box	40	In Commercial Distribution
Primary	M752TSBRF6640	HIBCC

Customer Contacts

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