AccessGUDID - DEVICE: Leica Biosystems (20849832022385)

GUDID

Device Identifier (DI) Information

Brand Name: Leica Biosystems
Version or Model: 39LC-500-3-L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 39LC-500-3-L
Company Name: Leica Biosystems Richmond, Inc.

Primary DI Number: 20849832022385
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 082930884 *Terms of Use

Device Description: IP ActivFlo Routine I, Taped, Aqua

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?
62970	Histology tissue cassette IVD, laboratory processing, single-use	A small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. 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
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:

Device Record Status

Public Device Record Key: 04e5013f-8ebf-432e-82d0-e2a815d45e5a
Public Version Date: April 23, 2025
Public Version Number: 1
DI Record Publish Date: April 15, 2025