AccessGUDID - DEVICE: Leica Biosystems (20849832016407)

GUDID

Device Identifier (DI) Information

Brand Name: Leica Biosystems
Version or Model: 3800084CL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3800084CL
Company Name: Leica Biosystems Richmond, Inc.

Primary DI Number: 20849832016407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1440
Labeler D-U-N-S® Number*: 082930884 *Terms of Use

Device Description: Apex Clipped Corner Slides, Pink

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
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:

Device Record Status

Public Device Record Key: 1836e594-7a38-4162-a8ca-dc9e027fd120
Public Version Date: July 09, 2025
Public Version Number: 1
DI Record Publish Date: July 01, 2025