FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693244480
·
Model: PapSpin™ Collection Fluid Kit B1001407 sold only as part of Shandon™ PapSpin™ K
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RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693244480
- Version / Model
- PapSpin™ Collection Fluid Kit B1001407 sold only as part of Shandon™ PapSpin™ K
- Catalog Number
- B1001407
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-29
- Public Version
- 1
- Public Version Date
- 2024-08-06
- Public Version Status
- New
- Public Device Record Key
- 4caab65a-466d-4435-a4c0-c9a7d9af2551
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| LEA | Preservative, Cytological | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57743 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693244480 | GS1 |