Sterilance Flex3 Depth Adjustable Safety Lancet - Sterilance Medical (Suzhou) Inc.

Duns Number:554434897

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More Product Details

Catalog Number

-

Brand Name

Sterilance Flex3 Depth Adjustable Safety Lancet

Version/Model Number

05-1526A

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

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Device Record Status

Public Device Record Key

21cfe651-f045-4656-b818-ea3370110514

Public Version Date

March 18, 2022

Public Version Number

1

DI Record Publish Date

March 10, 2022

Additional Identifiers

Package DI Number

36945630111908

Quantity per Package

1000

Contains DI Package

16945630111904

Package Discontinue Date

March 10, 2022

Package Status

Not in Commercial Distribution

Package Type

-

"STERILANCE MEDICAL (SUZHOU) INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 10