Medlance Plus, safety lancet - Sterile,single-use safety lancets for capillary - HTL STREFA S A

Duns Number:422528088

Device Description: Sterile,single-use safety lancets for capillary blood sampling.

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More Product Details

Catalog Number

7044

Brand Name

Medlance Plus, safety lancet

Version/Model Number

Universal, 21G 1.8mm

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

Lancet, Blood

Device Record Status

Public Device Record Key

80ba8945-833a-414c-bb2d-cb1dc3fc9006

Public Version Date

February 28, 2020

Public Version Number

1

DI Record Publish Date

February 20, 2020

Additional Identifiers

Package DI Number

15907506237119

Quantity per Package

10

Contains DI Package

05907506237112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"HTL STREFA S A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2