AccessGUDID - DEVICE: Epredia (00673693175524)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: 10% Neutral Buffered Formalin Prefilled Container
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RBBP-0480
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693175524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: 10% Neutral Buffered Formalin Prefilled Containers were designed to provide safe, cost-effective transportation, storage, and retrieval of pathology specimens. Prefilled specimen containers are non-sterile clear containers with screw-top lids. Each container is prefilled with 10% Neutral Buffered Formalin which is the industry standard for tissue fixation. The 10% Neutral Buffered Formalin is the traditional formulation for phosphate-buffered formalin. Size and Quantity: 24 cases. 480 mL filled to 240 mL. Total: 5.76

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?
57758	Neutral buffered formalin IVD	A neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. Some formulations may contain additional components such as zinc, alcohol, and/or eosin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IFP	Formalin, Neutral Buffered

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: 011ff465-60c5-4c92-aa3f-0a870f0f3145
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 2024