AccessGUDID - DEVICE: Epredia (00673693235068)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Tissue Capsule pads
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8453
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693235068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Tissue Capsule Pads otherwise known as biopsy sponges may be used in addition to the tissue cassette to hold tissue in place during processing.

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?
63784	Histological tissue cassette biopsy insert IVD	A flexible and porous material designed to securely hold a biopsy specimen within a tissue cassette, to prevent loss of the specimen during laboratory specimen processing (e.g., fixation, dehydration, infiltration) in preparation for subsequent cytological or histological examination. The flexible and porous material (e.g., paper, synthetic polymer) is intended to allow infiltration of reagents and maximize fluid-exchange during tissue processing. It is available in various forms (e.g., sheet, bag, foam pad) and is placed in a tissue processing cassette, with the biopsy specimen wrapped or contained inside it. 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: 5627fe00-ba77-4c78-ba8a-2865a860792f
Public Version Date: September 27, 2024
Public Version Number: 1
DI Record Publish Date: September 19, 2024