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

7288

Brand Name

Medlance Plus, safety lancet

Version/Model Number

Universal, needle 21G x 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

e3ba7742-5174-401d-9c6c-3ce7ed4bccc7

Public Version Date

November 11, 2019

Public Version Number

1

DI Record Publish Date

November 01, 2019

Additional Identifiers

Package DI Number

15907506237720

Quantity per Package

24

Contains DI Package

05907506237723

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