AccessGUDID - DEVICE: Epredia (00810041332011)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Adhesion Microscope Slides
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TT-80418218-PS-Y
Company Name: NEW ERIE SCIENTIFIC LLC

Primary DI Number: 00810041332011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 72
Labeler D-U-N-S® Number*: 361605223 *Terms of Use

Device Description: No description.

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?
57925	General specimen microscopy slide IVD, single-use	A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KEW	Slides, Microscope

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: 5a04ec91-ad96-431f-ae24-36f10a71fdf9
Public Version Date: March 21, 2025
Public Version Number: 1
DI Record Publish Date: March 13, 2025