Droplet Medlance Plus, safety lancets 9631

GUDID 85903999602280

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
Primary Device ID85903999602280
NIH Device Record Keyfa5d95b5-1e78-4a20-ab2f-6be3670ca58d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDroplet Medlance Plus, safety lancets
Version Model Number30G x 1.2mm
Catalog Number9631
Company DUNS422528088
Company NameHTL STREFA S A
Device Count50
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105903999602284 [Primary]
GS115903999602281 [Package]
Contains: 05903999602284
Package: shipper box [24 Units]
In Commercial Distribution
GS185903999602280 [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 Date2022-11-08
Device Publish Date2022-10-31

Devices Manufactured by HTL STREFA S A

50096295142995 - LEADER, pen needles2024-01-25 LEADER pen needles are sterile, single-use pen needles intended for use with pen injector devicec for the subcutaneous injection
10096295143000 - LEADER, pen needles2024-01-25 LEADER pen needles are sterile, single-use pen needles intended for use with pen injector devicec for the subcutaneous injection
15907996099976 - DropSafe™ Inject-Safe Barrier Bandage™2023-07-03 Barrier Bandage it’s intended to contain post-injection bleeding during a subcutaneous or intramuscular injection. The device
15903999603080 - Safe-T-Lance Plus, safety lancets2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
15903999603097 - Safe-T-Lance Plus, safety lancets2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
15903999603103 - Safe-T-Lance Plus, safety lancets2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
15903999603110 - Safe-T-Lance Plus, safety lancets2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof
15903999603127 - Safe-T-Lance Plus, safety lancets2023-04-06 Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare prof

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.