PremierPro Lancet - Lancet, Pressure, 30G x 1.5mm, Green, 100/bx1. - SVS LLC

Duns Number:831375089

Device Description: Lancet, Pressure, 30G x 1.5mm, Green, 100/bx1. Twist off the protective cap and pull it st Lancet, Pressure, 30G x 1.5mm, Green, 100/bx1. Twist off the protective cap and pull it straight out. 2. Press the safety lancet body firmly against the puncture site to activate the device. 3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume. Warnings1. Do not use if protective cap has been previously removed from lancet.2. Clean the injection site prior to use following established procedure.3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.

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More Product Details

Catalog Number

7553

Brand Name

PremierPro Lancet

Version/Model Number

7553

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)

-

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

286b28ad-bf77-40d7-b7a4-cb3b4849cb75

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

August 03, 2018

Additional Identifiers

Package DI Number

10811220030374

Quantity per Package

100

Contains DI Package

00811220030377

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"SVS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 486
2 A medical device with a moderate to high risk that requires special controls. 177
U Unclassified 1