M200 Series (Ceiling, Mobile) - AC 100 - 240 V, 79 - 102 VA, 50/60 Hz - DENTIS CO. ,LTD

Duns Number:694721181

Device Description: AC 100 - 240 V, 79 - 102 VA, 50/60 Hz

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

M200 Series (Ceiling, Mobile)

Version/Model Number

M200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FTD

Product Code Name

Lamp, Surgical

Device Record Status

Public Device Record Key

d4fc6856-27cd-48d4-8691-d4f051a3c121

Public Version Date

May 26, 2021

Public Version Number

5

DI Record Publish Date

December 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTIS CO. ,LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1118
2 A medical device with a moderate to high risk that requires special controls. 4011