n/a - Instrument, Diamond, Dental - Jota AG

Duns Number:480670983

Device Description: Instrument, Diamond, Dental

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More Product Details

Catalog Number

-

Brand Name

n/a

Version/Model Number

S858EF.FG.014

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

DZP

Product Code Name

Instrument, Diamond, Dental

Device Record Status

Public Device Record Key

2b2e1e1f-b426-4633-aca2-f3c0c1abc415

Public Version Date

September 23, 2021

Public Version Number

1

DI Record Publish Date

September 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JOTA AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 177