Epredia
- Primary DI
- 00673693228657
- Brand
- Epredia
- Company
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Model
- PapSpin™ Collection Fluid
- Catalog number
- 6768350
- Device description
- PapSpin™ Collection Fluid is used for the cytological fixation of gynecological samples. The collection fluid may be used independently or in conjunction with the EZ Megafunnels and Megafunnel cytoslides as found in the PapSpin™ Collection Fluid Kit.
- Published
- 2024-07-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| LEA | Preservative, Cytological |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LEA | Preservative, Cytological | Pathology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00673693228657 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00673693228657 | 00673693228657 | 673693228657 | 0673693228657 |
GMDN Terms
| Term | Definition |
|---|
| Cytology fixative solution IVD | An alcohol-based solution intended to be used as a fixative for a cytology specimen obtained directly from a patient, or processing of a clinical specimen, for subsequent preservation, transportation and/or in vitro diagnostic analysis. |
Regulatory Flags
- DUNS number
- 929504710
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00673693181723 | Epredia | Pen-Fix™ | 6105 | 2024-11-19 |
| 00673693063494 | Epredia | Microtome Knife, 12 CM, C | 2222004 | 2024-10-29 |
| 00673693063500 | Epredia | Microtome Knife, 16 CM, C | 152020 | 2024-10-29 |
| 00673693063753 | Epredia | Microtome Knife, 30CM, C | 152050 | 2024-10-29 |
| 00673693063760 | Epredia | Microtome Knife, 12 CM, D | 152060 | 2024-10-29 |
| 00673693063777 | Epredia | Microtome Knife, 16 CM, D | 152070 | 2024-10-29 |
| 00673693063784 | Epredia | Microtome Knife, 22 CM, D | 152080 | 2024-10-29 |
| 00673693063791 | Epredia | Microtome Knife, 25 CM, D | 152090 | 2024-10-29 |
| 00673693063807 | Epredia | Microtome Knife, 30 CM, D | 152100 | 2024-10-29 |
| 00673693063814 | Epredia | Tungsten Carbide Knife, 16 CM | 152120 | 2024-10-29 |
| 00673693064200 | Epredia | Adamas Blades for Disposable Magnetic Blade Carrie | 160010 | 2024-10-29 |
| 00673693064231 | Epredia | Adamas Blades for Disposable Magnetic Blade Carrie | 160040 | 2024-10-29 |
| 00673693226707 | Epredia | Tungsten Carbide D-Profile Microtome Knives | 5601006 | 2024-10-29 |
| 00673693263177 | Epredia | Microtome Knife D-Profile 240 mm | 2222006 | 2024-10-29 |
| 00673693568074 | Epredia | HistoPlast IM | 8331K | 2024-10-29 |
| 00673693220514 | Epredia | Microtome Knife C-Profile 240 mm | 2222005 | 2024-10-28 |
| 00673693232913 | Epredia | Stainless-Steel Microtome Knives 12.5 cm | 7619 | 2024-10-28 |
| 00673693233149 | Epredia | Standard Microtome Knife 125 mm | 7702 | 2024-10-28 |
| 00673693233187 | Epredia | Standard Microtome Knife 250 mm | 7704 | 2024-10-28 |
| 00673693233200 | Epredia | Stainless-Steel Microtome Knives 18.5 cm | 7719 | 2024-10-28 |
Other Devices Sharing Product Codes