STRADIS - CUSTOM DENTAL KIT MINOR ORAL SURGERY PACK - STRADIS MEDICAL, LLC

Duns Number:174262477

Device Description: CUSTOM DENTAL KIT MINOR ORAL SURGERY PACK

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More Product Details

Catalog Number

-

Brand Name

STRADIS

Version/Model Number

41022NMP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 2022

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EIA

Product Code Name

Unit, Operative Dental

Device Record Status

Public Device Record Key

a0a36501-3e94-4321-8085-df29c91260ff

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

January 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRADIS MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1226
2 A medical device with a moderate to high risk that requires special controls. 1431
U Unclassified 10