AccessGUDID - DEVICE: SEILER MEDICAL DIVISION (00860009669123)

GUDID

Device Identifier (DI) Information

Brand Name: SEILER MEDICAL DIVISION
Version or Model: AA3-400-LED
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED

Primary DI Number: 00860009669123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006265334 *Terms of Use

Device Description: The Alpha Air Series Microscopes 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, Ceiling, and Tabletop support structures are available for mounting and positioning the microscope in a comfortable position for the user. The microscope includes an integrated LED light source to illuminate the area within the microscopes field of view.

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?
62439	Dental surgical microscope	A light (optical) magnification instrument intended to be used to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures via transmission of white and/or ultraviolet light. It typically consists of a control unit, eyepiece and magnification controls, and a white and fluorescent light module to enable differentiation of natural tooth material suggesting dental pathology (e.g., caries, plaque, calculus/tartar) or composite material used for dental repairs. It may also include a camera for still image capture or video recording.	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: 137a8944-a383-4d86-9d75-f7ae4a9795df
Public Version Date: December 20, 2022
Public Version Number: 1
DI Record Publish Date: December 12, 2022