Catalog Number

4447010-02

Brand Name

SURECAN SAFETY II

Version/Model Number

4447010-02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

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

PTI

Product Code Name

Non-Coring (Huber) Needle

Public Device Record Key

eb276f29-8af0-483b-9054-efb56c012830

Public Version Date

March 03, 2020

Public Version Number

3

DI Record Publish Date

December 07, 2018

Package DI Number

04046964999918

Quantity per Package

5

Contains DI Package

04046964858130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton