FDR D-EVO G35s
- Primary DI
- 04547410235951
- Brand
- FDR D-EVO G35s
- Company
- FUJIFILM CORPORATION
- Model
- DR-ID 601 SE WIRED A E
- Device description
- The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect
- Published
- 2017-07-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| MQB | Solid state x-ray imager (flat panel/digital imager) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04547410235951 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04547410235951 | 04547410235951 | 4547410235951 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Handling Environment Humidity | 15 Percent (%) Relative Humidity | 80 Percent (%) Relative Humidity | |
| Handling Environment Temperature | 15 Degrees Celsius | 30 Degrees Celsius | |
| Storage Environment Atmospheric Pressure | 70 KiloPascal | 106 KiloPascal | |
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 90 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -30 Degrees Celsius | 50 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +018002728465 | xxx@xxx.xxx |
Regulatory Flags
- DUNS number
- 713565195
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 04547410480269 | FUJIFILM | VS-1000 | | 2026-05-22 |
| 04547410529128 | FUJIFILM | EG-S100XT | | 2026-05-22 |
| 04573596200865 | APERTO Lucent | MR-JCR-82 | Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT | 2026-05-22 |
| 04573596200889 | APERTO Lucent | MR-JC-81 | Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et | 2026-05-22 |
| 04573596200896 | APERTO Lucent | MR-JCR-83 | Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT | 2026-05-22 |
| 04573596200902 | APERTO Lucent | MR-CSC-81 | C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et | 2026-05-22 |
| 04573596200940 | APERTO Lucent | MR-QWC-81 | Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter | 2026-05-22 |
| 04573596200964 | APERTO Lucent | MR-MSC-81 | Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E | 2026-05-22 |
| 04573596200971 | APERTO Lucent | MR-QRC-81 | Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E | 2026-05-22 |
| 04573596201480 | APERTO Lucent | MR-QHC-81R | QD Head coil R MR-QHC-81R for APERTO Lucent | 2026-05-22 |
| 04573596201497 | APERTO Lucent | MR-QKC-83R | QD Knee coil R MR-QKC-83R for APERTO Lucent | 2026-05-22 |
| 04573596201503 | APERTO Lucent | MR-IBC-83 | Open body coil MR-IBC-83 for APERTO Lucent/APERTO | 2026-05-22 |
| 04573596202210 | APERTO Lucent | MR-QFC-82N | Flexible Body coil N(M) MR-QFC-82N for APERTO Luce | 2026-05-22 |
| 04573596202227 | APERTO Lucent | MR-QFC-83N | Flexible Body coil N(L) MR-QFC-83N for APERTO Luce | 2026-05-22 |
| 04547410571134 | FDR AQRO | DR-XD 1000 MBL ES US E | | 2026-03-20 |
| 14547410566250 | FUJIFILM | DH-084STR | | 2026-02-27 |
| 14547410566298 | FUJIFILM | DH-094STR | | 2026-02-27 |
| 14547410566335 | FUJIFILM | DH-104STR | | 2026-02-27 |
| 14547410566373 | FUJIFILM | DH-114STR | | 2026-02-27 |
| 14547410566410 | FUJIFILM | DH-124STR | | 2026-02-27 |
Other Devices Sharing Product Codes
xxx.xxx