Catalog Number

16-288

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

c5ac81d2-d1f5-45af-b811-338dcf26b3fb

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 30, 2021

Package DI Number

B924162882

Quantity per Package

300

Contains DI Package

B924162880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARDBOARD BOX