Catalog Number

400AW-10P

Brand Name

ACUWELL

Version/Model Number

400AW-10P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NRD

Product Code Name

Unit, Operative Dental, Accessories

Public Device Record Key

4e101e02-c9ca-4bd6-b091-c62951d397b9

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-