ROEKO Surgitip - Coltène/Whaledent GmbH + Co. KG

Duns Number:315494443

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


More Product Details

Catalog Number

462048

Brand Name

ROEKO Surgitip

Version/Model Number

462048

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

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

JOL

Product Code Name

Catheter And Tip, Suction

Device Record Status

Public Device Record Key

38ee7ada-ab67-425a-8b55-a7e39295ce5d

Public Version Date

March 29, 2022

Public Version Number

3

DI Record Publish Date

August 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COLTÈNE/WHALEDENT GMBH + CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 163
2 A medical device with a moderate to high risk that requires special controls. 24
U Unclassified 11