OCS ETCH GEL SYRINGE

Basic Information

• Brand Name: OCS ETCH GEL SYRINGE
• Primary DI: 10190886010730
• Version / Model: 008-031
• Company Name: G & H Wire Company, Inc.
• Labeler DUNS: 831465641
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-06
• Public Version: 7
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: 0a208b37-9d73-405c-8d19-d60d497ea9ca
• Distribution End Date: 2017-03-29

Device Description

OCS ETCH GEL SYRINGE 12GM 37% GREEN WITH 20 TIPS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXR	Applicator, Resin	Dental	872.3140	1
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	872.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60366	Dental material injection cannula, single-use	A rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.	No	Active
36153	Dental etching solution	An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190886010730	GS1

Customer Contacts

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