Stradis Medical, LLC.

Basic Information

• Brand Name: Stradis Medical, LLC.
• Primary DI: M752HCT5975OKB0
• Version / Model: HCT5975OK-B
• Company Name: STRADIS MEDICAL LLC
• Labeler DUNS: 043537671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-09
• Public Version: 2
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 232a2eee-4e24-451b-bd81-c9f3a8cc728d

Device Description

Oncology Stop Kit

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PWS	Chemotherapy Administration Kit	General Hospital	880.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44057	General surgical procedure kit, medicated	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M752HCT5975OKB0	HIBCC
Package	M752HCT5975OKB5	HIBCC		50	In Commercial Distribution

Customer Contacts

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