FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693171168
·
Model: Bouin's fluid 500 mL Ea.
·
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
- 00673693171168
- Version / Model
- Bouin's fluid 500 mL Ea.
- Catalog Number
- 88038
- 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
- 7dfdd182-9eeb-4a3c-bcd7-010c69f720d9
Device Description
Bouin’s Fluid is used as a primary fixative or as a mordant when doing special stains such as Masson’s Trichrome.
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 |
|---|---|---|---|---|
| IGN | Fluid, Bouin'S | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32948 | Bouin's solution IVD | A solution typically prepared with saturated picric acid, formaldehyde, and glacial acetic acid intended to be used as a fixative in the processing of biological tissues and clinical specimens. Bouin?s solution is frequently used as a fixative for chromosomes undergoing mitosis or meiosis in soft or delicate tissues such as testes, or gastrointestinal (GI) tract and endocrine tissues. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693171168 | GS1 |