Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 10304040118655
• Version / Model: 5701589
• Catalog Number: 5701589
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-05
• Public Version: 1
• Public Version Date: 2020-02-13
• Public Version Status: New
• Public Device Record Key: 6a8a34f8-cd0e-448f-9e36-1697bf065bb0

Device Description

Basic Laparotomy Procedure Pac

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJH	Orthopedic tray	General, Plastic Surgery	878.4800	1
PPF	Urinary irrigation kit	Gastroenterology, Urology	876.5130	2
LRO	General surgery tray	General, Plastic Surgery	878.4370	2
FDE	laparoscopy kit	Gastroenterology, Urology	876.1500	2
OGR	Ear, nose, and throat surgical tray	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47017	General-purpose syringe, single-use	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10304040118655	GS1