FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693344692
·
Model: Histogel™ Starter Kit 120V
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693344692
- Version / Model
- Histogel™ Starter Kit 120V
- Catalog Number
- HGSK-2050-1
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-04
- Public Version
- 1
- Public Version Date
- 2024-08-12
- Public Version Status
- New
- Public Device Record Key
- a379f0c3-cc2c-4ab9-9fcd-9f96bed3a121
Device Description
Histogel™ Starter Kit includes: Wonderblock Aluminum Cooling Blocks, Histogel™, Histogel™ Incubator & Tube Block, Disposable Pipettes and Thermometer (Mercury Free).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| LEA | Preservative, Cytological | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46944 | Test tube heater | An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature. | No | Active |
| 62706 | Agar powder IVD | A gelling agent intended to be used to create a solid culture medium for the isolation of single microbial colonies. It is presented as a powdered substance which is added to a heated liquid preparation which cools to form a solid medium. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693344692 | GS1 |