STRADIS HEALTHCARE

Basic Information

• Brand Name: STRADIS HEALTHCARE
• Primary DI: M75241206TSSP0
• Version / Model: 41206TSSP
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-02
• Public Version: 2
• Public Version Date: 2022-04-01
• Public Version Status: Update
• Public Device Record Key: 3f3faf4a-2bd9-4e41-89ae-9f79f76e50dd

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: 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
PWL	Oral Surgery Tray	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33969	Surgical vice, bench	A surgical clamping instrument usually composed of two jaws that are closed by a screw mechanism or lever intended to be used to hold another medical device in position during the process of bending, shaping, or aligning. It is attached to a workbench and is used sterile in the operating room (OR). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M75241206TSSP0	HIBCC
Package	M75241206TSSP1	HIBCC	CASE	5	In Commercial Distribution

Customer Contacts

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