FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693091688
·
Model: Denatured Ethanol High Purity
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693091688
- Version / Model
- Denatured Ethanol High Purity
- Catalog Number
- 9200-55
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-28
- Public Version
- 1
- Public Version Date
- 2024-08-05
- Public Version Status
- New
- Public Device Record Key
- 12967bf8-71da-4b1f-824a-847706a41c71
Device Description
Denatured Ethyl Alcohol is specifically designed for tissue processing and staining of histological and cytological specimens. The product is a clear, colorless reagent that is quality controlled. Denatured Ethyl Alcohol contains methyl alcohol, a known toxin. Precaution should be taken when handling Denatured Ethyl Alcohol. Protective gloves should be worn and work should be performed in a ventilated area. Denatured Ethyl Alcohol can be used with both open and closed tissue processors. It is also compatible with all manual staining procedures and automatic stainers. Denatured Ethyl Alcohol is a flammable product and must be stored in a flammable fire cabinet
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 |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55612 | Ethanol (ETOH) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693091688 | GS1 |