AccessGUDID - DEVICE: AincA® (B005E1260506)

GUDID

Device Identifier (DI) Information

Brand Name: AincA®
Version or Model: E-126-050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E-126-050
Company Name: ANESTHESIA ASSOCIATES, INC.

Primary DI Number: B005E1260506
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 002065670 *Terms of Use

Device Description: Tooth Protector, Gardent, Adult Size, Molded in USA, Santoprene, Bag of 50 Pieces Bulk Packaged

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BRW	Protector, dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a50dcc3b-2874-48d6-872d-944c7fc7b9db
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021