FDA UDI
In Commercial Distribution
🇺🇸 United States
Phosphor Storage Plate Guide Size 1
DI: D6787356611
·
Model: 73566-1
·
AIR TECHNIQUES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phosphor Storage Plate Guide Size 1
- Primary DI
- D6787356611
- Version / Model
- 73566-1
- Company Name
- AIR TECHNIQUES, INC.
- Labeler DUNS
- 043835081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-08
- Public Version
- 1
- Public Version Date
- 2018-07-09
- Public Version Status
- New
- Public Device Record Key
- 0839f321-93d6-4494-a9db-9fb71e732b58
Device Description
An accessory used to help guide the phosphor storage plate used in our ScanX Digital Radiography Device System.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| IWZ | Film, Radiographic | Radiology | 892.1840 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31828 | Dental x-ray system beam alignment device | A mechanical device that is used to support and position dental x-ray film and to serve as a guide for proper physical alignment of the x-ray tube with the positioned dental x-ray film during dental x-ray imaging procedures. Depending on the device design, it can be used as a guide for either intraoral or extraoral dental x-ray systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D6787356611 | HIBCC |
Customer Contacts
- Phone
- 1800-247-8324
- [email protected]