HNM MEDICAL - ø3.2mm STEINMANN PIN, 9" DOUBLE END TROCAR, FULLY - HNM STAINLESS, LLC.

Duns Number:806754185

Device Description: ø3.2mm STEINMANN PIN, 9" DOUBLE END TROCAR, FULLY THREADED

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More Product Details

Catalog Number

HKW-21-090032

Brand Name

HNM MEDICAL

Version/Model Number

HKW-21-090032

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100736

Product Code Details

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Device Record Status

Public Device Record Key

63f7e7e5-eea5-418a-95f1-f3d184c1b127

Public Version Date

June 07, 2019

Public Version Number

1

DI Record Publish Date

May 30, 2019

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