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Seiler Medical Division

FDA UDI

Class I (US FDA UDI)

by Seiler Instrument And Manufacturing Company, Incorporated

Identity

Trade Name
SEILER MEDICAL DIVISION FDA UDI
Generic Name
General-purpose surgical microscope FDA UDI
Device Name
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. FDA UDI
Model / Reference
3DV-300 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00852728008833 FDA UDI
FDA Product Code
EPT FDA UDI
GMDN Term
General-purpose surgical microscope FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose surgical microscope

Seiler Medical Division by Seiler Instrument And Manufacturing Company, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose surgical microscope.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Seiler Instrument And Manufacturing Company, Incorporated

Sources (1)

  • FDA UDI b6a72fef-ab9a-41f6-b35b-541d4d9da377 33 fields · synced Jun 8, 2026