Catalog Number

-

Brand Name

SureFine Pen Needle 29GX12.7mm

Version/Model Number

SM-0015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K152877,K152877,K152877,K152877

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

5f4deec2-d866-4083-aedc-52c1ca7b975a

Public Version Date

May 09, 2019

Public Version Number

1

DI Record Publish Date

May 01, 2019

Package DI Number

08800052600591

Quantity per Package

6

Contains DI Package

08800052600584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case