AincA®

Basic Information

• Brand Name: AincA®
• Primary DI: B005E1260103
• Version / Model: E-126-010
• Catalog Number: E-126-010
• Company Name: ANESTHESIA ASSOCIATES, INC.
• Labeler DUNS: 002065670
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 1
• Public Version Date: 2021-04-08
• Public Version Status: New
• Public Device Record Key: 1703ed2b-26d4-445a-848e-3364457597d9

Device Description

Tooth Protector, Gardent, Adult Size, Molded in USA, Santoprene, Package of 10 Individually Bagged Units

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: Yes
• MRI Safety: MR Safe
• 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
BRW	Protector, dental	Anesthesiology	868.5820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17595	Intubation teeth protector	A sterile curved device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures. Such protection can be required when the patient is resisting the intubation by clenching their teeth which can be damaged against the metal or plastic blade of the intubation laryngoscope, and/or if the patient has bad teeth that are liable to inadvertent damage, and/or if this is normal hospital procedure to counter liability claims. 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	B005E1260100	HIBCC
Primary	B005E1260103	HIBCC

Customer Contacts

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