Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693222235
- Version / Model
- Tissue-Marking Dyes Green
- Catalog Number
- 3120128
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-06
- Public Version
- 1
- Public Version Date
- 2024-08-14
- Public Version Status
- New
- Public Device Record Key
- 5ddedcf0-45d2-4dde-82d7-95057f729e49
Device Description
Tissue Marking Dyes are intended as an aid in the orientation, of excised surgical specimens through frozen sectioning, processing, and sectioning, and subsequent microscopic examination of tissues. The marking of multiple margins with these dyes is especially useful for identification in skin biopsies, a technique known as Moh’s surgery. These dyes are normally applied to fresh tissue but may also be used with fixed tissue. Whether fresh or fixed, the tissue should be blotted to remove excess fluid from the surface before applying the dye. Tissue Marking Dyes will permanently bond to the tissue 1 to 2 minutes after application. The tissue can then be frozen and prepared for sectioning or placed in formalin or other fixatives and processed for paraffin embedding.
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 |
|---|---|---|---|---|
| LEE | Stains, Dye Solution | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63615 | Biopsy tissue marking dye kit IVD | A coloured solution intended to be used to permanently mark the surgical margins and/or other general areas of interest on a tissue biopsy specimen; it is not intended to stain a tissue section for the visualization of intra/extracellular elements. It is one of a set, or a set of multiple colours (e.g., red, blue, black, green, violet and/or orange) which can withstand tissue processing (e.g., tissue fixation, freezing) without fading or bleeding. Applicators for precise marking or spreading of the dye onto the tissue specimen may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693222235 | GS1 |