Catalog Number

OTDP Lancing Device US

Brand Name

OneTouch Delica Plus Lancing Device

Version/Model Number

02397301

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K221546,K221546

Product Code

QRK

Product Code Name

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Public Device Record Key

60b57cde-2967-47ef-bff3-343b0d77a3ae

Public Version Date

September 28, 2022

Public Version Number

2

DI Record Publish Date

February 28, 2019

Package DI Number

20812608030051

Quantity per Package

24

Contains DI Package

00812608030057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box