STRADIS HEALTHCARE

Basic Information

• Brand Name: STRADIS HEALTHCARE
• Primary DI: M75257015220
• Version / Model: 570-1522
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-06
• Public Version: 2
• Public Version Date: 2023-02-07
• Public Version Status: Update
• Public Device Record Key: 2bed3eea-fb0a-42b5-9880-132043eff7b7
• Distribution End Date: 2023-02-06

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
FOD	Device, Occlusion, Umbilical	General Hospital	880.5950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13983	Umbilical cord tape	A thin, flat strip of synthetic and/or natural material which is used as a tie or suture around the umbilical cord of a newborn infant after severance from the placenta. It typically consists of a braided strip of cotton thread and or spun polyester yarn and comes in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M75257015220	HIBCC

Customer Contacts

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