Catalog Number

PRO-1079-94

Brand Name

K2M General Instruments

Version/Model Number

PRO-1079-94

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

HWT

Product Code Name

TEMPLATE

Public Device Record Key

86c31530-a62e-45ba-9813-07a722630ed7

Public Version Date

April 01, 2022

Public Version Number

1

DI Record Publish Date

March 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-