Epredia
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693227063
- Version / Model
- Single Cytofunnel™, Brown
- Catalog Number
- 5991043
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-25
- Public Version
- 1
- Public Version Date
- 2024-08-02
- Public Version Status
- New
- Public Device Record Key
- fe4f04a0-5ec0-43bc-a0b9-261033b2e64d
Device Description
The Single Cytofunnel is a disposable sample chamber with attached brown or white filter card and cap. The device allows for a single cell deposition area of 6 mm and accommodates samples up to 0.5ml for the white filter cards and 0.4ml for the brown filter cards. The fFilter cards are preattached and allow for different absorbency rates. Brown filter cards are optimal for scan specimens such as cerebrospinal fluid. The stainless steel Cytoclip, available separately, are used to mount the Cytofunnel to the slide for use with the Cytospin™ Cytocentrifuge. Single Cytofunnels are single use only.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IFB | Cytocentrifuge | Pathology | 864.3300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63732 | Cytological centrifuge funnel IVD | A small, tapered receptacle designed to be fitted into a cytological centrifuge/sample concentrator, and intended to contain and help concentrate clinical specimen suspension cells into thin-layer preparations by depositing them directly onto a microscope slide during centrifugation for subsequent examination. It is in the form of a conical-shaped plastic receptacle; some types have a slot for inserting a microscope slide. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693227063 | GS1 |