Mixing pad - VOCO GmbH

Duns Number:316699578

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More Product Details

Catalog Number

-

Brand Name

Mixing pad

Version/Model Number

2302

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

-

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

EJB

Product Code Name

Handle, Instrument, Dental

Device Record Status

Public Device Record Key

bf8beae1-f2de-48a7-9d5f-3b9a2da6f389

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

May 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VOCO GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 396
U Unclassified 5