AccessGUDID - DEVICE: Leica Biosystems Lamp Housing 106, 12V 100W, 2 Lens, 0,55 (00849832010555)

GUDID

Device Identifier (DI) Information

Brand Name: Leica Biosystems Lamp Housing 106, 12V 100W, 2 Lens, 0,55
Version or Model: 23MIC4058
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Leica Biosystems Richmond, Inc.

Primary DI Number: 00849832010555
Issuing Agency: GS1
Commercial Distribution End Date: March 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 082930884 *Terms of Use

Device Description: Leica Biosystems Lamp Housing 106, 12V 100W, 2 Lens, 0,55

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?
16438	Microscope light source	A mains electricity (AC-powered) device that is exclusively designed to provide a microscope with an external source of light to light up the viewing field which may be, e.g., directly under the magnification system (a slide) or a field of surgical intervention. This device may be a simple lamp, or utilize fibreoptic cables to carry a cold light forward to the site. This device is not built into the microscope and must be identified using this GMDN code. If the light source is built-in, then it shall be considered as part of the parent device and the product identification will then follow that of the parent device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: ad04bbc4-2e70-435d-b27d-e9e64dc7b456
Public Version Date: March 12, 2025
Public Version Number: 3
DI Record Publish Date: January 30, 2017