Identity
- Trade Name
- Epredia FDA UDI
- Generic Name
- Microtome blade IVD, single-use FDA UDI
- Device Name
- The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use. FDA UDI
- Model / Reference
- HP35N Ultra Microtome Blade FDA UDI
- Description
- The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use. FDA UDI
Identifiers
- Catalog Number
- 3151735 FDA UDI
- Primary DI / UDI-DI
- 00673693591508 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
No
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
Yes
FDA UDI
Category: Microtome blade IVD, single-use
Epredia by Richard-Allan Scientific LLC — 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
- Richard-Allan Scientific LLC
Sources (1)
- FDA UDI a5f8a3ce-25b8-4524-9916-5436b5b461c1 34 fields · synced Jun 8, 2026