FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693084222
·
Model: Zinc Buffered Formalin Prefilled Container
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693084222
- Version / Model
- Zinc Buffered Formalin Prefilled Container
- Catalog Number
- 591201ZF
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-24
- Public Version
- 1
- Public Version Date
- 2024-08-01
- Public Version Status
- New
- Public Device Record Key
- a61674a8-c7a3-4ffc-a214-7159eb830e93
Device Description
Fixation is the initial and most important step of histology specimen preparation in pathology. 10% Neutral Buffered Formalin is the most used fixative in the histology laboratory, but in certain circumstances, other fixatives may be desired according to tissue type or subsequent pretreatment or staining technique. Zinc Buffered Formalin maintains the traditional formulation of 10% Neutral Buffered Formalin but with the addition of zinc. The addition of zinc provides better nuclear detail in tissue samples.
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 |
|---|---|---|---|---|
| LDY | Fixative, Formalin-Containing | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57758 | Neutral buffered formalin IVD | A neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. Some formulations may contain additional components such as zinc, alcohol, and/or eosin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693084222 | GS1 |