Pip - Safety Lancet - AMITY HOLDINGS, LLC

Duns Number:016069284

Device Description: Safety Lancet

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More Product Details

Catalog Number

902

Brand Name

Pip

Version/Model Number

902

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 27, 2025

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)

Yes

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

ce7f0231-862d-454e-8ed3-208c3c27b2ff

Public Version Date

October 15, 2020

Public Version Number

2

DI Record Publish Date

August 27, 2020

Additional Identifiers

Package DI Number

00732671009029

Quantity per Package

100

Contains DI Package

10732671109023

Package Discontinue Date

August 27, 2025

Package Status

In Commercial Distribution

Package Type

Chipboard Carton

"AMITY HOLDINGS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 5