Catalog Number

1103-166S

Brand Name

SONTEC WIRE PASSER

Version/Model Number

1103-166S

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

-

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

-

Product Code

HXI

Product Code Name

PASSER, WIRE, ORTHOPEDIC

Public Device Record Key

a41f3e66-72d4-4ced-a513-cea74c0ce8e3

Public Version Date

June 10, 2019

Public Version Number

3

DI Record Publish Date

September 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-