AccessGUDID - DEVICE: Leica CAMERA, JAI CV-M4 (00849832012207)

GUDID

Device Identifier (DI) Information

Brand Name: Leica CAMERA, JAI CV-M4
Version or Model: 23CAM0011R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Leica Biosystems Richmond, Inc.

Primary DI Number: 00849832012207
Issuing Agency: GS1
Commercial Distribution End Date: March 07, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 082930884 *Terms of Use

Device Description: Leica CAMERA, JAI CV-M4

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:	No
Prescription Use (Rx):	Yes
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?
35576	Surgical microscope still camera	An electro-optical device intended to be used to capture and generate an enlarged image of a microscopic field for examination of a clinical specimen during a surgical procedure. It is designed to attach to a surgical microscope and utilizes the lens system for magnification of the microscope’s field; the images generated are used for subsequent clinical decision-making. This device may be a digital or photographic camera; some types may in addition be used with laboratory microscopes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOY	DEVICE, AUTOMATED CELL-LOCATING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042542	000

Device Exempt from Premarket Submission: No 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: 5f0c429d-5503-4ef7-81b7-fca0eb08589e
Public Version Date: March 10, 2025
Public Version Number: 5
DI Record Publish Date: October 12, 2017