FDA UDI
In Commercial Distribution
🇺🇸 United States
IMAGE DIAGNOSTICS, INC
DI: 00850977007973
·
Model: Protego MRS System for Toshiba Table Tops w/Metric Accessory Rails
·
IMAGE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMAGE DIAGNOSTICS, INC
- Primary DI
- 00850977007973
- Version / Model
- Protego MRS System for Toshiba Table Tops w/Metric Accessory Rails
- Catalog Number
- A800-0007
- Company Name
- IMAGE DIAGNOSTICS, INC.
- Labeler DUNS
- 608235214
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-02
- Public Version
- 1
- Public Version Date
- 2023-08-10
- Public Version Status
- New
- Public Device Record Key
- 89b2d889-a9a9-495d-9d97-7a061a699c27
Device Description
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,TOSHIBA,#A800-0007
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IWX | Barrier, Control Panel, X-Ray, Movable | Radiology | 892.6500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38373 | Radiation shielding panel, portable/mobile | A portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850977007973 | GS1 |
Customer Contacts
- Phone
- 978-829-0009
- [email protected]