KABIERSKE POWDER BLOWER CANNULA - KABIERSKE POWDER BLOWER CANNULA - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: KABIERSKE POWDER BLOWER CANNULA

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More Product Details

Catalog Number

465-400F

Brand Name

KABIERSKE POWDER BLOWER CANNULA

Version/Model Number

465-400F

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

KCL

Product Code Name

BLOWER, POWDER, ENT

Device Record Status

Public Device Record Key

4fc9f855-d479-4f05-a48c-5e649ac12545

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414