Stradis Medical, LLC

Basic Information

• Brand Name: Stradis Medical, LLC
• Primary DI: M752EAREF885500
• Version / Model: EA-REF885-50
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-07
• Public Version: 3
• Public Version Date: 2023-02-07
• Public Version Status: Update
• Public Device Record Key: 8ae6faf9-bff4-4bd6-b11f-ef9557c6cbcd
• Distribution End Date: 2023-02-06

Device Description

PVP 3/4 oz

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
35246	Surgical patient preparation kit	A collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M752EAREF885505	HIBCC	outer box	50	Not in Commercial Distribution	2023-02-06
Primary	M752EAREF885500	HIBCC

Customer Contacts

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