FDA UDI
In Commercial Distribution
🇺🇸 United States
Mikroscan
DI: 00860002275628
·
Model: SL5-E
·
MIKROSCAN TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mikroscan
- Primary DI
- 00860002275628
- Version / Model
- SL5-E
- Company Name
- MIKROSCAN TECHNOLOGIES, INC.
- Labeler DUNS
- 079395952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-02
- Public Version
- 1
- Public Version Date
- 2020-01-10
- Public Version Status
- New
- Public Device Record Key
- cc6bc652-66cb-47e3-ad97-fa950c007036
Device Description
The dual mode SL5-E system from Mikroscan offers the user two completely separate and distinctly different capabilities in one convenient device. The user selects either the live microscope mode using a fully functional, remotely controlled robotic microscope or a static digital pathology scanner for the creation of whole-slide images. The protection features of the equipment may be impaired if the device is used in a manner not specified by Mikroscan.
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
- 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 |
|---|---|---|---|---|
| IBJ | Light, Microscope | Pathology | 864.3600 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62575 | Microscope slide digital imaging scanner IVD | A mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860002275628 | GS1 |
Customer Contacts
- Phone
- +1 (760) 893-8095
- [email protected]