BAHADIR USA - Dental BOTTOM PERFORATED 310X190X65MM - BAHADIR USA LLC

Duns Number:794759212

Device Description: Dental BOTTOM PERFORATED 310X190X65MM

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

BAHADIR USA

Version/Model Number

Y 506.06A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131407

Product Code Details

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

d19c9150-2b18-46ff-b71c-2dc3c2b7acb3

Public Version Date

July 08, 2021

Public Version Number

6

DI Record Publish Date

February 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BAHADIR USA LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 296
2 A medical device with a moderate to high risk that requires special controls. 550