Catalog Number

-

Brand Name

Jelco

Version/Model Number

972106

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"

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

K895705,K895705,K895705

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

b97065c5-d418-4fca-a23e-f21a41b2bb83

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

January 12, 2017

Package DI Number

10351688060440

Quantity per Package

50

Contains DI Package

00351688060443

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX