Uni-Etch 32% Empty Syringe Pkg

Basic Information

• Brand Name: Uni-Etch 32% Empty Syringe Pkg
• Primary DI: D757X80582P1
• Version / Model: X-80582P
• Catalog Number: X-80582P
• Company Name: BISCO INC.
• Labeler DUNS: 053529939
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-06
• Public Version: 3
• Public Version Date: 2023-01-18
• Public Version Status: Update
• Public Device Record Key: e1e62341-6553-49f4-b1f8-67b06f0d01c4
• Distribution End Date: 2023-01-17

Device Characteristics

• Single Use: No
• 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: No
• 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
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63696	Dental etching solution syringe	A hand-held, manual dental instrument consisting of a barrel (cylinder) with plunger intended to be used to dispense dental etching solution (etchant) to a patient’s tooth/teeth. It is intended to be filled once and used on multiple patients; disposable dispensing tips may be included. This device is reusable until the contents of the syringe are exhausted.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D757X80582P1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			sixe text