ORABLOC

Basic Information

• Brand Name: ORABLOC
• Primary DI: 08053610771879
• Version / Model: Orabloc Needle twenty7L
• Company Name: TECNOFAR SPA
• Labeler DUNS: 428682363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-06-22
• Public Version: 1
• Public Version Date: 2023-06-30
• Public Version Status: New
• Public Device Record Key: 4609e422-ee79-4000-8c29-7ffa3e5a5e6d

Device Description

Orabloc Needle twenty7L

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZM	Needle, Dental	Dental	872.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12740	Dental syringe needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	08053610771923	GS1
Primary	08053610771879	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	27	Gauge