Catalog Number

1005

Brand Name

MediHeel

Version/Model Number

1005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 01, 2025

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)

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

97cb1058-915a-4de7-bb78-41d1badd9a05

Public Version Date

June 09, 2020

Public Version Number

1

DI Record Publish Date

June 01, 2020

Package DI Number

20732671210054

Quantity per Package

10

Contains DI Package

00732671010056

Package Discontinue Date

June 01, 2025

Package Status

In Commercial Distribution

Package Type

Corrugate Carton