Catalog Number

OTD Safety 23g US/CA 200

Brand Name

OneTouch Delica Safety

Version/Model Number

024-207

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

-

Product Code

FMK

Product Code Name

Lancet, Blood

Public Device Record Key

c03a4b30-3e78-41b7-99d4-97ca56d5a58b

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 26, 2021

Package DI Number

20812608030235

Quantity per Package

24

Contains DI Package

00812608030231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box