FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693078238
·
Model: 10% Neutral 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
- 00673693078238
- Version / Model
- 10% Neutral Buffered Formalin Prefilled Container
- Catalog Number
- 531201
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-17
- Public Version
- 1
- Public Version Date
- 2024-07-25
- Public Version Status
- New
- Public Device Record Key
- 2c29beb8-2094-4c0d-8c28-901d07c1f298
Device Description
10% Neutral Buffered Formalin Prefilled Containers were designed to provide safe, cost-effective transportation, storage, and retrieval of pathology specimens. Prefilled specimen containers are non-sterile clear containers with screw-top lids. Each container is prefilled with 10% Neutral Buffered Formalin which is the industry standard for tissue fixation. The 10% Neutral Buffered Formalin is the traditional formulation for phosphate-buffered formalin. Size and Quantity: 100 per case. 120 mL filled to 80 mL. Total: 8 Liters
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 |
|---|---|---|---|---|
| IFP | Formalin, Neutral Buffered | 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 | 00673693078238 | GS1 |