CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10888439254334
• Version / Model: SENDHDOCLE
• Catalog Number: SENDHDOCLE
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-13
• Public Version: 1
• Public Version Date: 2019-05-21
• Public Version Status: New
• Public Device Record Key: b4520d0e-b672-4b4c-99c8-69f882afcbe5

Device Description

DENTAL OMFS PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFX	General purpose dental tray	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45152	Dental anaesthesia injection kit	A collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. It typically includes a syringe, a needle, a needle protection mechanism, and a plunger. This device does not contain the pharmaceuticals which are typically held within a cartridge produced to fit the syringe. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50888439254332	GS1	CASE	2	In Commercial Distribution
Primary	10888439254334	GS1