AccessGUDID - DEVICE: SEILER MEDICAL DIVISION (00860009669192)

GUDID

Device Identifier (DI) Information

Brand Name: SEILER MEDICAL DIVISION
Version or Model: SXS820
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED

Primary DI Number: 00860009669192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006265334 *Terms of Use

Device Description: The SeilerScope is Seiler Microscope's entry level microscope. Standard 4x,10x,40x,and 100x(oil) achromat lenses are perfect for most offices or learning institutions.

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?
35484	Basic light microscope	A magnification instrument designed with a standard microscope configuration [the object viewed through an ocular(s) from above] used to magnify and study specimens and small objects by transmitted visible light. It is widely used in laboratories and for research and in healthcare facilities where there is a need for such magnification. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a nosepiece to support the objectives, a specimen stage, a condenser to focus the light on the specimen, and a source of light [e.g., tungsten (W), halogen] and light port.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IBJ	Light, Microscope

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: 9e6b8290-20f2-473c-b65b-24c01fc219f8
Public Version Date: March 10, 2023
Public Version Number: 1
DI Record Publish Date: March 02, 2023