FDA UDI
In Commercial Distribution
🇺🇸 United States
DelWorks
DI: 00858340006097
·
Model: 3.0
·
Del Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DelWorks
- Primary DI
- 00858340006097
- Version / Model
- 3.0
- Company Name
- Del Medical, Inc.
- Labeler DUNS
- 078671236
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-09
- Public Version
- 2
- Public Version Date
- 2022-06-22
- Public Version Status
- Update
- Public Device Record Key
- d0307830-4299-46de-bc2b-efd5de8a3d62
Device Description
PORTABLE WORKSTATION Wirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistance The DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.
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
- No
- 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 |
|---|---|---|---|---|
| 40935 | Diagnostic x-ray digital imaging system workstation | A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858340006097 | GS1 |
Customer Contacts
- Phone
- 847-288-7031
- [email protected]