Key Surgical K-Wires and Steinmann Pins - Steinmann Pins, Double trocar threaded, 0.189" - KEY SURGICAL, INC.

Duns Number:604056226

Device Description: Steinmann Pins, Double trocar threaded, 0.189" (4.8mm) diameter, 9" long

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More Product Details

Catalog Number

-

Brand Name

Key Surgical K-Wires and Steinmann Pins

Version/Model Number

KI-71-769

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

K102845,K102845

Product Code Details

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Device Record Status

Public Device Record Key

d5e837c0-f625-4491-b06a-c59bcdf8ae87

Public Version Date

September 08, 2021

Public Version Number

3

DI Record Publish Date

December 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KEY SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 326
2 A medical device with a moderate to high risk that requires special controls. 219