Catalog Number

-

Brand Name

POLYPERF SAFE

Version/Model Number

U112208

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"

-

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

K063631,K063631

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

3392dc68-5551-4aca-aec0-851b2f376d1b

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

September 18, 2016

Package DI Number

13661234014238

Quantity per Package

12

Contains DI Package

03661234014231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-