FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693180757
·
Model: Neg-50™ Pink
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693180757
- Version / Model
- Neg-50™ Pink
- Catalog Number
- 6502P
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-02
- Public Version
- 1
- Public Version Date
- 2024-08-12
- Public Version Status
- New
- Public Device Record Key
- 887bed06-0e7e-457e-b0ac-dc221029f74f
Device Description
Neg-50™ is formulated to yield high-quality sections even down to -50°C without chatter and is available in blue, green, orange, pink, yellow and colorless.
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 |
|---|---|---|---|---|
| KEQ | Media, Mounting, Water Soluble | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57739 | Tissue freezing/embedding medium IVD | A tissue freezing and embedding material intended to be used as an embedding matrix for the preparation and processing of frozen sections from biological tissues or clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693180757 | GS1 |