Catalog Number

OTDP Lancet Bag 33g US/CA

Brand Name

OneTouch Delica Plus Lancet

Version/Model Number

013-026

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K221546,K221546,K221546

Product Code

QRK

Product Code Name

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

Public Device Record Key

e02413b6-d700-426e-b27a-c90a6cb50e80

Public Version Date

September 28, 2022

Public Version Number

2

DI Record Publish Date

January 31, 2022

Package DI Number

20812608030037

Quantity per Package

1000

Contains DI Package

00812608030033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box