Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693214391
- Version / Model
- Biopsy Cassette I
- Catalog Number
- 1000970
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-19
- Public Version
- 1
- Public Version Date
- 2024-09-27
- Public Version Status
- New
- Public Device Record Key
- d5eaf628-50d5-43f1-92b7-1749b6d3b424
Device Description
Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.
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 |
|---|---|---|---|---|
| IDZ | Cassettes, Tissue | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62970 | Histology tissue cassette IVD, laboratory processing, single-use | A small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693214391 | GS1 |