Syringe Cover

Basic Information

• Brand Name: Syringe Cover
• Primary DI: 00883205015440
• Version / Model: 249
• Catalog Number: 249
• Company Name: ULTRADENT PRODUCTS, INC.
• Labeler DUNS: 013369913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-28
• Public Version: 3
• Public Version Date: 2018-11-22
• Public Version Status: Update
• Public Device Record Key: d44c40be-6aa6-467d-9068-cfb08e0a7b89

Device Description

Syringe Covers 300pk

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NPK	Barrier, synthetic, intraoral	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17977	Medical equipment handle cover, single-use, non-sterile	A non-sterile device designed specifically to cover the handle of a piece of medical equipment (e.g., examination/treatment light) to provide a hygienic barrier between the handle and the hand of a healthcare professional. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00883205015440	GS1

Customer Contacts

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