ATOMO - ATOMO Sensor Sleeves, #5 - ATOMO DENTAL, INC.

Duns Number:088480717

Device Description: ATOMO Sensor Sleeves, #5

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More Product Details

Catalog Number

-

Brand Name

ATOMO

Version/Model Number

AA1247

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

NRD

Product Code Name

Unit, Operative Dental, Accessories

Device Record Status

Public Device Record Key

37046630-c212-4565-945a-802879263ad4

Public Version Date

September 13, 2022

Public Version Number

1

DI Record Publish Date

September 05, 2022

Additional Identifiers

Package DI Number

D883AA12473

Quantity per Package

36

Contains DI Package

D883AA12471

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