STRADIS HEALTHCARE

Basic Information

• Brand Name: STRADIS HEALTHCARE
• Primary DI: M75257032050
• Version / Model: 570-3205
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-29
• Public Version: 1
• Public Version Date: 2023-01-06
• Public Version Status: New
• Public Device Record Key: 96c55999-e918-44a4-8253-c1f31dad0842

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
OFT	Spinal Epidural Anesthesia Kit	Anesthesiology	868.5120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66346	Local/regional anaesthesia support kit	A collection of noninvasive devices intended to support a local and/or regional anaesthesia procedure (e.g., spinal/epidural anaesthesia, peripheral nerve block). It includes supportive devices such as drapes, bowls, towels, and dressing forceps; neither a needle, anaesthesia catheter, nor medication is included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M75257032050	HIBCC

Customer Contacts

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