ATOMO - ATOMO Non-woven sponge 4"x4" - ATOMO DENTAL, INC.

Duns Number:088480717

Device Description: ATOMO Non-woven sponge 4"x4"

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More Product Details

Catalog Number

-

Brand Name

ATOMO

Version/Model Number

AA0032

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)

-

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

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Device Record Status

Public Device Record Key

55fb96c4-7089-4d13-98f4-15d7035b5df7

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 09, 2022

Additional Identifiers

Package DI Number

D883AA00323

Quantity per Package

10

Contains DI Package

D883AA00321

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

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