Unistik Touch - Unistik Touch - Contact Activated Safety Lancet - - OWEN MUMFORD LIMITED

Duns Number:217266915

Device Description: Unistik Touch - Contact Activated Safety Lancet - 30G x 1.5mm - 200 count - sterile single Unistik Touch - Contact Activated Safety Lancet - 30G x 1.5mm - 200 count - sterile single use safety lancet

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More Product Details

Catalog Number

-

Brand Name

Unistik Touch

Version/Model Number

AT 1424

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FMK

Product Code Name

Lancet, Blood

Device Record Status

Public Device Record Key

a114d2f1-9a41-4379-ab61-7e9a160c761e

Public Version Date

June 24, 2021

Public Version Number

2

DI Record Publish Date

March 26, 2021

Additional Identifiers

Package DI Number

00384701424038

Quantity per Package

20

Contains DI Package

00384701424014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"OWEN MUMFORD LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1