BAHADIR USA - METAL IDENTIFICATION LABEL, YELLOW - BAHADIR USA LLC

Duns Number:794759212

Device Description: METAL IDENTIFICATION LABEL, YELLOW

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More Product Details

Catalog Number

970601

Brand Name

BAHADIR USA

Version/Model Number

Y820.12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

78a61ea3-593d-4fa4-9302-6e565439e2b5

Public Version Date

July 08, 2021

Public Version Number

6

DI Record Publish Date

July 29, 2016

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