FDA.report

AincA®

Primary DI
B005E1260500
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
E-126-050
Catalog number
E-126-050
Device description
Tooth Protector, Gardent, Adult Size, Molded in USA, Santoprene, Bag of 50 Pieces Bulk Packaged
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BRWProtector, dental

Product Code Classifications

CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B005E1260506PrimaryHIBCC0
B005E1260500Unit of UseHIBCC0

GMDN Terms

TermDefinition
Intubation teeth protectorA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(760)744-6561Solutions@AincA.com

Regulatory Flags

DUNS number
002065670
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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