Catalog Number

7140

Brand Name

MediSafe Solo, safety lancet

Version/Model Number

23G

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)

-

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

15a93f1f-081a-492c-b6fa-5d6f98449e19

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

October 30, 2020

Package DI Number

15901549097198

Quantity per Package

10

Contains DI Package

05901549097191

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipper