BAHADIR USA - PERFORATED TRAY 539X252X45 - BAHADIR USA LLC

Duns Number:794759212

Device Description: PERFORATED TRAY 539X252X45

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More Product Details

Catalog Number

-

Brand Name

BAHADIR USA

Version/Model Number

Y 181.05

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

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

66d507b3-0e40-45ec-9877-ec25387265e0

Public Version Date

September 16, 2022

Public Version Number

9

DI Record Publish Date

August 14, 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