FDA UDI
In Commercial Distribution
🇺🇸 United States
IMAGE DIAGNOSTICS INC
DI: 00850061871060
·
Model: MOBILE RADIATION BARRIER DISPOSABLE COVERS,CASE
·
IMAGE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- IMAGE DIAGNOSTICS INC
- Primary DI
- 00850061871060
- Version / Model
- MOBILE RADIATION BARRIER DISPOSABLE COVERS,CASE
- Catalog Number
- X800-0117
- Company Name
- IMAGE DIAGNOSTICS, INC.
- Labeler DUNS
- 608235214
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-10-23
- Public Version
- 1
- Public Version Date
- 2024-10-31
- Public Version Status
- New
- Public Device Record Key
- c32b9180-baad-4321-880d-65b25a0f729c
Device Description
IDI,PROTEGO,COVER,DISPOSABLE,MOBILE RADIATION BARRIER,CASE OF 25 POUCHES,#X800-0117
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MMP | Cover, Barrier, Protective | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40655 | Basic diagnostic x-ray system table, powered | A powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850061871053 | GS1 | ||||
| Primary | 00850061871060 | GS1 |
Customer Contacts
- Phone
- 1-978-829-0009
- [email protected]