Stradis Medical, LLC.

Basic Information

• Brand Name: Stradis Medical, LLC.
• Primary DI: M752HCT1313B0
• Version / Model: HCT1313B
• Company Name: STRADIS MEDICAL LLC
• Labeler DUNS: 043537671
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-30
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 84b9cd8c-3cee-4c0c-9ddc-27d1502033cb

Device Description

Dressing Port Kit W/ Biopatch

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
MCY	Wound Dressing Kit	General Hospital	880.5075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34059	Wound dressing kit, medicated	A collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M752HCT1313B5	HIBCC	Outer Box	30	In Commercial Distribution
Primary	M752HCT1313B0	HIBCC

Customer Contacts

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