FDA UDI
In Commercial Distribution
🇺🇸 United States
DMC-EZ
DI: 00850018049047
·
Model: DMC-EZ 8500
·
Storage Solutions Technology Group Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DMC-EZ
- Primary DI
- 00850018049047
- Version / Model
- DMC-EZ 8500
- Catalog Number
- DMC-EZ 8500
- Company Name
- Storage Solutions Technology Group Inc.
- Labeler DUNS
- 194045303
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-11
- Public Version
- 1
- Public Version Date
- 2021-02-19
- Public Version Status
- New
- Public Device Record Key
- be4abb30-1e23-4e61-9743-6fbd3bdc6132
Device Description
DICOM Media Creator - 8500 Thermal
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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | Radiology | 892.2010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64454 | DICOM image data disc-recording unit | A desktop unit intended to interface with an off-the-shelf computer (not included) to collect digital imaging and communications in medicine (DICOM) image data and record (burn) it onto a compact disc (CD) and/or digital video disc (DVD); it may in addition include a disc-label printer. It includes the appropriate software; it does not have any image processing or analysis capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850018049047 | GS1 |
Customer Contacts
- Phone
- 408-350-3450
- [email protected]