Trays - Container and Baskets for TMR Mounting Hardware - FLEXBAR MACHINE CORPORATION

Duns Number:047644935

Device Description: Container and Baskets for TMR Mounting Hardware and Rings

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More Product Details

Catalog Number

72152

Brand Name

Trays

Version/Model Number

72152

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

K102146

Product Code Details

Product Code

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

e979a014-6a5c-4b23-b83e-336dae0d4b29

Public Version Date

July 08, 2021

Public Version Number

6

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLEXBAR MACHINE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 882
2 A medical device with a moderate to high risk that requires special controls. 595