Catalog Number

-

Brand Name

PMT CORPORATION HALO

Version/Model Number

1201-35

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K090733

Product Code

HAX

Product Code Name

Tong, Skull For Traction

Public Device Record Key

2df410d9-4e31-47c9-82cf-3c5ebf5e93b2

Public Version Date

July 20, 2021

Public Version Number

1

DI Record Publish Date

July 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-