FDA UDI
In Commercial Distribution
🇺🇸 United States
Mikroscan
DI: 00860002275604
·
Model: SL5
·
MIKROSCAN TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mikroscan
- Primary DI
- 00860002275604
- Version / Model
- SL5
- 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
- 875f6c13-ff17-4e1f-bda8-754ea747eabb
Device Description
The dual mode SL5 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. *For Research Use Only. Not for use in diagnostic procedures.
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 | 00860002275604 | GS1 |
Customer Contacts
- Phone
- +1 (760) 893-8095
- [email protected]