TCV-FAC-21W(SBF)(46060) - This device is intended to remove droplets - TOKYO GIKEN INC.

Duns Number:692497670

Device Description: This device is intended to remove droplets scattered from the oral cavity. This equipment This device is intended to remove droplets scattered from the oral cavity. This equipment is an electrical powered suction pumps as suction source.

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


More Product Details

Catalog Number

-

Brand Name

TCV-FAC-21W(SBF)(46060)

Version/Model Number

W134

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

-

Prescription Use (Rx)

Yes

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

EBR

Product Code Name

Unit, Suction Operatory

Device Record Status

Public Device Record Key

21248e29-3aa9-4323-a7d4-8886aa0be64e

Public Version Date

October 09, 2020

Public Version Number

1

DI Record Publish Date

October 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOKYO GIKEN INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8