AccessGUDID - DEVICE: Airway Armor® (00840161304780)

GUDID

Device Identifier (DI) Information

Brand Name: Airway Armor®
Version or Model: 50Z960TRI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRC DENTAL PRODUCTS, INC.

Primary DI Number: 00840161304780
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064783913 *Terms of Use

Device Description: "Airway Armor 15pk Trial Kit 5 x Small 5 x Medium 5 x Large"

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
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?
63666	Dental throat shield	A piece of semi-flexible or spongy material intended to be fitted behind the teeth or in the oropharynx of a patient to obstruct the pharynx and prevent aspiration/ingestion of debris (e.g., tooth particles, dental materials) during a dental procedure. Also referred to as a throat pack, it is typically made of textile and/or synthetic polymer materials, and may be designed with perforations for ventilation or intended to be used in conjunction with an endotracheal tube during an oral surgery procedure involving general anaesthesia; some types have an attached cord/thread to facilitate device retrieval. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIE	Dam, Rubber

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: 5aea078b-754b-4701-80c9-e570413e7b79
Public Version Date: November 02, 2022
Public Version Number: 1
DI Record Publish Date: October 25, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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