Catalog Number

-

Brand Name

STERILANCE

Version/Model Number

02-2201

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

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

QRL

Product Code Name

Multiple Use Blood Lancet For Single Patient Use Only

Public Device Record Key

5a49d5cb-f597-4583-8797-9b71f04abd08

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Package DI Number

36945630113865

Quantity per Package

100

Contains DI Package

06945630113864

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-