Identity
- Trade Name
- ClaraCut™ Blades FDA UDI
- Generic Name
- Microtome blade IVD, single-use FDA UDI
- Device Name
- Microtome blade cartridge for use in SectionStar™ auto-sectioning machine for the preparation of pathology specimens. Microtome blades are used for sectioning a variety of sample types, including fixed, paraffin embedded cell and tissue blocks. FDA UDI
- Model / Reference
- 900-00022 FDA UDI
- Description
- Microtome blade cartridge for use in SectionStar™ auto-sectioning machine for the preparation of pathology specimens. Microtome blades are used for sectioning a variety of sample types, including fixed, paraffin embedded cell and tissue blocks. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860012688913 FDA UDI
- FDA Product Code
- IDL FDA UDI
- GMDN Term
- Microtome blade IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microtome blade IVD, single-use
ClaraCut™ Blades by Clarapath, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clarapath, Inc.
Sources (1)
- FDA UDI d5e332fa-7bd3-484c-ab32-a0abb4d9d3a4 33 fields · synced May 30, 2026