AccessGUDID - DEVICE: Epredia (00673693758321)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Cassette 2 Biopsy
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B851738BE
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693758321
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IDZ	Cassettes, Tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f972bae0-c4db-48ad-828a-31d5b8c16c74
Public Version Date: September 27, 2024
Public Version Number: 1
DI Record Publish Date: September 19, 2024