Catalog Number

-

Brand Name

HolstOR

Version/Model Number

H-250

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

9dac1021-b599-4a62-8382-5e48b06a5e28

Public Version Date

January 29, 2020

Public Version Number

1

DI Record Publish Date

January 21, 2020

Package DI Number

09349967000854

Quantity per Package

25

Contains DI Package

09349967000847

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper