Device
Airway Armor® - Throat Guard - Medium - 1 Count
Manufacturer
ZIRC DENTAL PRODUCTS, INC.
ZIRC DENTAL PRODUCTS, INC.
Model: 5Z960MD
DI: 00840161311900
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Airway Armor® - Throat Guard - Medium - 1 Count
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3ecd6b38-0109-4a0e-a6fb-076eddc75fdb
Distribution Status:
In Commercial Distribution
DUNS Number:
064783913
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00840161311993
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
25
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00840161311900
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00840161311900
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 63666
Name: Dental throat shield
Definition:
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.
FDA Product Codes
EIE
Dam, Rubber