PremierPro - Button Activated Safety Lancet, 18G x 1.8mm, - SVS LLC

Duns Number:831375089

Device Description: Button Activated Safety Lancet, 18G x 1.8mm, Sterile, Green, 100/bx

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More Product Details

Catalog Number

7521

Brand Name

PremierPro

Version/Model Number

7521

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

5ca8a7c7-14b2-40db-9731-89868fa522ba

Public Version Date

September 16, 2020

Public Version Number

1

DI Record Publish Date

September 08, 2020

Additional Identifiers

Package DI Number

10818566013481

Quantity per Package

10

Contains DI Package

00818566013484

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