HammerTube System - K-Wire, Double Ended Trocar Tip, 1.4mm x 150mm - PARAGON 28, INC.

Duns Number:042961576

Device Description: K-Wire, Double Ended Trocar Tip, 1.4mm x 150mm

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More Product Details

Catalog Number

P99-292-1415

Brand Name

HammerTube System

Version/Model Number

P99-292-1415

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K171715

Product Code Details

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Device Record Status

Public Device Record Key

7844f957-33e2-4290-a108-feed85b47c48

Public Version Date

October 25, 2019

Public Version Number

1

DI Record Publish Date

October 17, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARAGON 28, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1122
2 A medical device with a moderate to high risk that requires special controls. 3564