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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
ENT surgical microscope FDA UDI
Device Name
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. FDA UDI
Model / Reference
EVO-ENT3SLIM FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00852728008567 FDA UDI
FDA Product Code
EPT FDA UDI
GMDN Term
ENT 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: ENT 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 ENT 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 98a10d67-4302-453e-ae76-417a6c19d15f 33 fields · synced Jun 6, 2026