DropSafe Prolance, safety lancets 9647

GUDID 15903999602380

Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare professionals and lay users.

HTL STREFA S A

Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use
Primary Device ID15903999602380
NIH Device Record Key7087d7ca-f858-47c5-ba5a-7b781b035dd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDropSafe Prolance, safety lancets
Version Model Number28G x 1.6mm
Catalog Number9647
Company DUNS422528088
Company NameHTL STREFA S A
Device Count200
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com
Phone+48422700010
Emailinfo@htl-strefa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105903999602383 [Primary]
GS115903999602380 [Package]
Contains: 05903999602383
Package: shipper box [10 Units]
In Commercial Distribution
GS185903999602389 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-11
Device Publish Date2022-11-03

On-Brand Devices [DropSafe Prolance, safety lancets]

15903999602359Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
15903999602403Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
15903999602397Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
15903999602380Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
15903999602373Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In
15903999602366Safety lancets are sterile, single use medical devices intended for capillary blood sampling. In

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