Catalog Number

7045

Brand Name

Medlance Plus, safety lancet

Version/Model Number

Extra, 21G 2.4 mm

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

-

Product Code

FMK

Product Code Name

Lancet, Blood

Public Device Record Key

8c1f1460-d8b3-4329-976a-d382e03343bc

Public Version Date

February 28, 2020

Public Version Number

1

DI Record Publish Date

February 20, 2020

Package DI Number

15907506237126

Quantity per Package

10

Contains DI Package

05907506237129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper