Catalog Number

-

Brand Name

Deltec

Version/Model Number

21-2770-24

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

K021999,K021999

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

2b93357a-34d6-4d53-b46b-c880a5d08115

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

January 24, 2017

Package DI Number

30610586025635

Quantity per Package

12

Contains DI Package

10610586025631

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX