AccessGUDID - DEVICE: Zeiss Axio Observer (04064897000082)

GUDID

Device Identifier (DI) Information

Brand Name: Zeiss Axio Observer
Version or Model: Axio Observer 7
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 431007-9904-000
Company Name: Carl Zeiss Microscopy GmbH

Primary DI Number: 04064897000082
Issuing Agency: GS1
Commercial Distribution End Date: September 17, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 537598935 *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:	No
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?
17440	Inverted-stage light microscope	A magnification instrument designed with illumination placed at the top with the stage (the specimen platform) below, and the optics on the bottom for microscopic study of large specimens by transmitted light. It is typically used in the laboratory for investigation and research. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a specimen stage, a condenser to focus the light on the specimen, and a source of light. It is typically used for the examination of tissue cultures in all types of culture vessels (e.g., Petri dishes, culture bottles) and also in microtest and microtitre plates.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MTX	Microscope and microscope accessories, reproduction, assisted

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
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d04e873-ce85-44cf-8480-8e6af1d6e5db
Public Version Date: October 11, 2024
Public Version Number: 2
DI Record Publish Date: September 28, 2022