Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693181846
- Version / Model
- Mark-It™ Tissue Marking Dye Kit
- Catalog Number
- 5000
- 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
- 251a274f-564c-4454-b79e-cdbe13f16290
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
- 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 |
|---|---|---|---|---|
| LEE | Stains, Dye Solution | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63616 | Biopsy tissue marking dye applicator IVD | A device intended to apply marking dye on a tissue biopsy specimen. It is in the form of a stick and is typically made of wood or plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693181846 | GS1 |