FDA UDI
In Commercial Distribution
🇺🇸 United States
FDR ES G43
DI: 04547410361353
·
Model: DR-ID 1272 SE E
·
FUJIFILM CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FDR ES G43
- Primary DI
- 04547410361353
- Version / Model
- DR-ID 1272 SE E
- Company Name
- FUJIFILM CORPORATION
- Labeler DUNS
- 713565195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-05
- Public Version
- 3
- Public Version Date
- 2023-12-11
- Public Version Status
- Update
- Public Device Record Key
- 684bb6d8-2b81-4226-98f9-5239594e324e
Device Description
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications.
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
- 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 |
|---|---|---|---|---|
| MQB | Solid state x-ray imager (flat panel/digital imager) | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37645 | Stationary basic diagnostic x-ray system, digital | An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04547410361353 | GS1 |
Customer Contacts
- Phone
- +018002728465
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142003 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 460x460x15mm |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 50 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 80 Percent (%) Relative Humidity