Stylus

Basic Information

• Brand Name: Stylus
• Primary DI: 00848782026388
• Version / Model: 52-3261
• Catalog Number: 52-3261
• Company Name: Surgical Specialties México, S. de R.L. de C.V.
• Labeler DUNS: 812762226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-29
• Public Version: 1
• Public Version Date: 2021-04-06
• Public Version Status: New
• Public Device Record Key: 13657fcf-185f-4cb9-b68b-6cdd415d8018

Device Description

SLIT KNIFE FULL HDL-3.2MM ANG

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMF	KNIFE, SURGICAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37445	Manual scalpel blade, single-use	An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10848782026385	GS1	Box	6	In Commercial Distribution
Primary	00848782026388	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K861947	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3.2 MM