EMPIRE SURGICAL INSTRUMENTS COMPANY

Basic Information

• Brand Name: EMPIRE SURGICAL INSTRUMENTS COMPANY
• Primary DI: B92311138PP1
• Version / Model: 11-138-PP
• Catalog Number: 11-138-PP
• Company Name: EMPIRE SURGICAL INSTRUMENTS COMPANY
• Labeler DUNS: 645772133
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-09-01
• Public Version: 2
• Public Version Date: 2022-09-23
• Public Version Status: Update
• Public Device Record Key: 1218bcb1-bd96-4773-8d48-270a7dea1307

Device Description

IRIS SCISSORS 4.5" STR PP

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRW	Scissors, General, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58949	General-purpose surgical scissors, single-use	A hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B92311138PP2	HIBCC	Cardboard Box	1000	In Commercial Distribution
Unit of Use	B92311138PP11	HIBCC
Primary	B92311138PP1	HIBCC

Customer Contacts

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