FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693073189
·
Model: Mounting Medium
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693073189
- Version / Model
- Mounting Medium
- Catalog Number
- 4111
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-30
- Public Version
- 1
- Public Version Date
- 2024-08-07
- Public Version Status
- New
- Public Device Record Key
- 119c965b-412f-4f19-b548-91715a72037f
Device Description
Mounting Medium is a toluene-based rapid-drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage.
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 |
|---|---|---|---|---|
| LEB | Mounting Media | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43550 | Microscopy mounting medium IVD | A substance intended to be used to create a seal between a microscope slide, clinical specimen and/or coverslip, to preserve the specimen and/or the integrity of any dye(s) used for staining, and enhance image quality during microscopic examination. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693073189 | GS1 |