AccessGUDID - DEVICE: Epredia (00673693228718)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Nu-Clear™ I
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6769008
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693228718
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Nu-Clear™ is intended to be used as an aid in hematoxylin staining for the diagnosis of general pathology specimens.

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?
43584	Acid-alcohol solution IVD	An acid-alcohol solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LED	Stains, Chemical Solution

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: ffec2c80-1545-4c5e-88fb-38182a2110ba
Public Version Date: September 09, 2024
Public Version Number: 1
DI Record Publish Date: August 30, 2024