AccessGUDID - DEVICE: ATMOS (04250365177251)

GUDID

Device Identifier (DI) Information

Brand Name: ATMOS
Version or Model: i View 21 PRO
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ATMOS MedizinTechnik GmbH & Co. KG

Primary DI Number: 04250365177251
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 319591939 *Terms of Use

Device Description: The device is a microscope intended to give a magnified illuminated spacial view on human tissue for diagnostic and treatment purposes. It also can be used for surgical purposes.

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?
12538	ENT surgical microscope	A light (optical) magnification instrument designed to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing. It typically consists of a stereo microscope (standard or modified) and a mobile floor stand or wall or ceiling mount. It is usually held by an adjustable arm attached to the support mechanism and equipped with motorized focusing, adjustable magnification systems (manual, zoom, or both), backup lamps, and inclined tubes. Dual- or multiple-observation capability and the optical integration of still, motion picture, and TV cameras are common features.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSO	Microscope, Surgical, General & Plastic Surgery

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d1231f96-043a-4a31-bd60-f53090f21c02
Public Version Date: December 05, 2024
Public Version Number: 1
DI Record Publish Date: November 27, 2024