FDA UDI
In Commercial Distribution
🇺🇸 United States
Airway Armor®
DI: 00840161304827
·
Model: 50Z963-360
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Airway Armor®
- Primary DI
- 00840161304827
- Version / Model
- 50Z963-360
- Company Name
- ZIRC DENTAL PRODUCTS, INC.
- Labeler DUNS
- 064783913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-25
- Public Version
- 1
- Public Version Date
- 2022-11-02
- Public Version Status
- New
- Public Device Record Key
- 592e4d80-0627-4b18-a36a-7bffc162b8b1
Device Description
"Airway Armor 9pk for use in the Isolation Power Pack 3 x Small 3 x Medium 3 x Large "
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EIE | Dam, Rubber | Dental | 872.6300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840161304827 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 11.7 | Centimeter | |
| Width | 16.5 | Centimeter |