Catalog Number

1201-83

Brand Name

PMT® CORPORATION HALO

Version/Model Number

1201-83

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 23, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090733,K090733

Product Code

HAX

Product Code Name

Tong, Skull For Traction

Public Device Record Key

c3b182e4-8474-445c-b21c-489538539d30

Public Version Date

November 24, 2020

Public Version Number

4

DI Record Publish Date

January 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-