Catalog Number

16-254-LR

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

e6b8a360-d132-45a2-9f16-032b7d765de0

Public Version Date

March 08, 2021

Public Version Number

2

DI Record Publish Date

January 31, 2021

Package DI Number

B92416254LR2

Quantity per Package

600

Contains DI Package

B92416254LR0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARDBOARD BOX