BLUE AND GREEN

Basic Information

• Brand Name: BLUE AND GREEN
• Primary DI: 00840018649385
• Version / Model: OTN115/4
• Company Name: NORDENT MANUFACTURING INC
• Labeler DUNS: 053187985
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-22
• Public Version: 1
• Public Version Date: 2020-07-30
• Public Version Status: New
• Public Device Record Key: 2a59b59c-e6c8-4ffc-a2b0-e2fffa38f9b3

Device Description

B&G ORTHO SCALER 115 #4 HANDLE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37413	Orthodontic ligature director	A hand-held dental instrument used to tuck and direct ligatures under the archwire or bracket wings or to push archwires or auxiliaries into position. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840018649385	GS1