Catalog Number

-

Brand Name

OLSEN WEBSTER NEEDLE HOLDER

Version/Model Number

132-359Q

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

-

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

FHQ

Product Code Name

HOLDER, NEEDLE, GASTROENTEROLOGIC

Public Device Record Key

9011e104-0dc9-4d0f-b1d9-3ed861dc4721

Public Version Date

March 11, 2021

Public Version Number

3

DI Record Publish Date

February 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-