Stradis

Basic Information

• Brand Name: Stradis
• Primary DI: M752ZZ14091
• Version / Model: ZZ 1409
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-06-18
• Public Version: 1
• Public Version Date: 2022-06-27
• Public Version Status: New
• Public Device Record Key: c19eec03-2576-424f-8d96-7de449bcb104

Device Description

Forceps

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
HTD	Forceps	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64034	Dental dressing forceps, single-use	A sterile, hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	M752ZZ14090	HIBCC
Primary	M752ZZ14091	HIBCC

Customer Contacts

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