AccessGUDID - DEVICE: SEILER MEDICAL DIVISION (00852728008833)

GUDID

Device Identifier (DI) Information

Brand Name: SEILER MEDICAL DIVISION
Version or Model: 3DV-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED

Primary DI Number: 00852728008833
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006265334 *Terms of Use

Device Description: The 3D Surgical Microscopes are produced and sold by Seiler Instrument & Manufacturing Co., Inc. There are many types of medical procedures that benefit from the high magnification provided by a surgical microscope. The microscope offers the user an illuminated and magnified view of the field of interest. Floor, Wall, and Ceiling support structures are available for mounting and positioning the microscope in a comfortable position for the user. The microscope includes a LED light source to illuminate the area within the field of view. A light guide/cable transfers the output from the light source to the optic pod. The light is then projected through the objective lens to the area of interest, providing relatively shadow-free illumination. The light source also provides two DC outputs to provided power to the 3D display and other electronics. The user must wear polarized 3D glasses while viewing the 3D display to view the illuminated and magnified view of the field of interest. Focus, magnification, and brightness controls offer image options to the user.

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?
35191	General-purpose surgical microscope	A general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EPT	Microscope, Surgical

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: b6a72fef-ab9a-41f6-b35b-541d4d9da377
Public Version Date: December 09, 2022
Public Version Number: 1
DI Record Publish Date: December 01, 2022