Catalog Number

27-204

Brand Name

Miltex®

Version/Model Number

27-204

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"

-

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

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

dc6b321f-22f4-41fa-b170-df9472656e3a

Public Version Date

February 05, 2020

Public Version Number

4

DI Record Publish Date

September 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-