ASSI

Basic Information

• Brand Name: ASSI
• Primary DI: 00841645122197
• Version / Model: ASSI.93826
• Company Name: ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
• Labeler DUNS: 055870299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-29
• Public Version: 1
• Public Version Date: 2020-07-07
• Public Version Status: New
• Public Device Record Key: 52633f64-d1ba-49ad-a520-b10895907101

Device Description

Thornton Radial Marker 4 Blades, 12.5mm O.D.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMR	Marker, Ocular	Ophthalmic	886.4570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62727	Skin marking guide, reusable	A device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841645122197	GS1