Catalog Number

HPRO-330

Brand Name

HolstOR Pro

Version/Model Number

330mm

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"

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

-

Product Code

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Public Device Record Key

b7624db9-383d-462e-948e-97db4005d49f

Public Version Date

June 11, 2018

Public Version Number

1

DI Record Publish Date

May 09, 2018

Package DI Number

09349967002902

Quantity per Package

50

Contains DI Package

09349967002896

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Carton