droplet ® personal lancets - droplet ® personal lancets are sterile, single - HTL STREFA S A

Duns Number:422528088

Device Description: droplet ® personal lancets are sterile, single use medical devices intended to be used wit droplet ® personal lancets are sterile, single use medical devices intended to be used with a lancing device by lay users for capillary blood sampling.

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More Product Details

Catalog Number

7167

Brand Name

droplet ® personal lancets

Version/Model Number

30G

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"

-

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

99579860-ae62-4f26-b22c-6bd0c6ea42b4

Public Version Date

December 09, 2019

Public Version Number

1

DI Record Publish Date

December 01, 2019

Additional Identifiers

Package DI Number

15907506237881

Quantity per Package

72

Contains DI Package

05907506237884

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