Catalog Number

-

Brand Name

Special Tap Sleeve Assembly

Version/Model Number

16399-0010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

fe47c975-4c26-401a-883e-3b7e2430881f

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-