FDA UDI
In Commercial Distribution
🇺🇸 United States
Clarapath™ SectionStar™
DI: 00860012688944
·
Model: 810-00001
·
Clarapath, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Clarapath™ SectionStar™
- Primary DI
- 00860012688944
- Version / Model
- 810-00001
- Company Name
- Clarapath, Inc.
- Labeler DUNS
- 079469240
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-22
- Public Version
- 1
- Public Version Date
- 2024-10-30
- Public Version Status
- New
- Public Device Record Key
- 7342f718-0336-4aba-9d6e-a351f7e8f2bb
Device Description
Automated tissue sectioning and transfer system
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
- Yes
- 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 |
|---|---|---|---|---|
| IDO | Microtome, Rotary | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15158 | Rotary microtome IVD | A precision cutting instrument intended to be used to cut tissue sections, fixed in paraffin wax, into thin slices for subsequent in vitro diagnostic analysis. The device has a vertically-fixed knife which cuts through the paraffin block vertically, and a flywheel mechanism which cuts sections with each turn. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012688944 | GS1 | ||||
| Previous | 00198168976302 | GS1 |