FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693226943
·
Model: TPX Sample Chamber Closure Caps
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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
- 00673693226943
- Version / Model
- TPX Sample Chamber Closure Caps
- Catalog Number
- 59910025
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-18
- Public Version
- 1
- Public Version Date
- 2024-10-28
- Public Version Status
- New
- Public Device Record Key
- 8a2ea070-b443-426d-9131-ef9cf62b6987
Device Description
The TPX Sample Chamber is a reusable sample chamber used in conjunction with a closure cap, Cytoclip and 2-hole disposable filter card (Brown) and (White). The Cytoclip is used to mount the Cytofunnel to the Cytospin™ Cytocentrifuge. The filter cards are designed with two cut-outs for easy insertion with the TPX chamber although only one deposition area is visualized. TPX chambers are reusable and autoclavable.
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00673693226943 | GS1 |