Catalog Number

-

Brand Name

Key Surgical K-Wire and Pin Covers

Version/Model Number

C-093

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

452ac941-3749-420a-839c-c8a871006b7c

Public Version Date

September 08, 2021

Public Version Number

3

DI Record Publish Date

December 09, 2020

Package DI Number

10849771003646

Quantity per Package

12

Contains DI Package

00849771003649

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box