HNM MEDICAL - STERILIZATION CONTAINER, BOTTOM NON PERFORATED, - HNM STAINLESS, LLC.

Duns Number:806754185

Device Description: STERILIZATION CONTAINER, BOTTOM NON PERFORATED, 11 3/4"X5 1/2"X2 3/4", NO LID

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More Product Details

Catalog Number

HNM-405.07A

Brand Name

HNM MEDICAL

Version/Model Number

HNM-405.07A

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

5aebc39c-ca42-4c40-af9e-a2b1afb9cb40

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

April 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HNM STAINLESS, LLC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 729