Embrace Safety Lancet - Embrace Safety Lancet 21G/2.2mm 100ct. - OMNIS HEALTH, LLC

Duns Number:824763358

Device Description: Embrace Safety Lancet 21G/2.2mm 100ct.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Embrace Safety Lancet

Version/Model Number

SHN02GX21.22

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FMK

Product Code Name

Lancet, Blood

Device Record Status

Public Device Record Key

fa5bfdd1-926e-48c5-bd9a-07a70c50a52f

Public Version Date

July 13, 2021

Public Version Number

1

DI Record Publish Date

July 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OMNIS HEALTH, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 12