FDA UDI
In Commercial Distribution
🇺🇸 United States
Grid (14x17)
DI: 04547410467871
·
Model: DR-XD 3000 GRID3543 E
·
FUJIFILM CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Grid (14x17)
- Primary DI
- 04547410467871
- Version / Model
- DR-XD 3000 GRID3543 E
- Company Name
- FUJIFILM CORPORATION
- Labeler DUNS
- 713565195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-28
- Public Version
- 3
- Public Version Date
- 2024-05-30
- Public Version Status
- Update
- Public Device Record Key
- 6032bc10-7e2d-4b3e-906d-ae8ce3c56407
Device Description
A grid for 14" x 17" flat panel sensor mounted onto DR-XD 3000FX.
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | 892.1650 | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37646 | Mobile general-purpose fluoroscopic x-ray system, digital | A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04547410467871 | GS1 |
Customer Contacts
- Phone
- +018002728465
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212956 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 377 mm x 453 mm x 1.1 mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal