Catalog Number

16-274-LRS

Brand Name

CROWN SURGICAL

Version/Model Number

NEEDLE HOLDER

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

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

ebcfac81-d580-4849-8ebc-f7e617c20f22

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 30, 2021

Package DI Number

B92416274LRS2

Quantity per Package

400

Contains DI Package

B92416274LRS0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARDBOARD BOX