Catalog Number

-

Brand Name

Embrace Lancet

Version/Model Number

SHN02GM0123

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

-

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

QRK

Product Code Name

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Public Device Record Key

b0f41f79-8f19-4b6d-a905-26987fbf70db

Public Version Date

October 28, 2022

Public Version Number

2

DI Record Publish Date

July 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-