Medlance, safety lancet - Medlance, safety lancets are sterile, single use - HTL STREFA S A

Duns Number:422528088

Device Description: Medlance, safety lancets are sterile, single use medical devices intended for capillary b Medlance, safety lancets are sterile, single use medical devices intended for capillary blood sampling.

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More Product Details

Catalog Number

7007

Brand Name

Medlance, safety lancet

Version/Model Number

28G 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

a3f35226-e74f-4704-8192-1f1255705d63

Public Version Date

August 20, 2021

Public Version Number

1

DI Record Publish Date

August 12, 2021

Additional Identifiers

Package DI Number

15907996095480

Quantity per Package

6

Contains DI Package

05907996095483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"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