Henry Schein

Basic Information

• Brand Name: Henry Schein
• Primary DI: 10304040025984
• Version / Model: 5700346
• Catalog Number: 5700346
• Company Name: HENRY SCHEIN, INC.
• Labeler DUNS: 012430880
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2019-08-21
• Public Version Status: Update
• Public Device Record Key: 607ced8a-6f1f-4eb7-88fa-5be541ad67cf

Device Description

Retreat GRP Cannules

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVL	CORD, RETRACTION	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
38795	Dental material injection cannula, reusable	A rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10304040025984	GS1
Unit of Use	00304040025987	GS1

Premarket Submissions

Submission Number	Supplement Number
K050180	000