Catalog Number

16-256-PP

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

5bc77120-6935-4603-a7a8-7b3695c10859

Public Version Date

March 10, 2021

Public Version Number

1

DI Record Publish Date

March 02, 2021

Package DI Number

B92416256PP2

Quantity per Package

600

Contains DI Package

B92416256PP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARDBOARD BOX