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SA300 Series

FDA UDI

Class I (US FDA UDI)

by Dentis Co. , Ltd

Identity

Trade Name
SA300 Series FDA UDI
Generic Name
Medical monitor/light mount FDA UDI
Device Name
Suspension Arm(SA300 Series) is intended to be used to provide easy angle adjustment and movement of the surgical luminaire. FDA UDI
Model / Reference
SA300-002000 FDA UDI
Description
Suspension Arm(SA300 Series) is intended to be used to provide easy angle adjustment and movement of the surgical luminaire. FDA UDI

Identifiers

Primary DI / UDI-DI
08800053092302 FDA UDI
FDA Product Code
FQO FDA UDI
GMDN Term
Medical monitor/light mount FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4960 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

Yes

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: Medical monitor/light mount

SA300 Series by Dentis Co. , Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical monitor/light mount.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentis Co. , Ltd

Sources (1)

  • FDA UDI 91a7826b-7028-446c-89d4-fac9535a55c9 33 fields · synced May 30, 2026