Unistik 3

GUDID 00384701027024

Unistik 3 Safety Lancet Gentle - 30G

OWEN MUMFORD LIMITED

Manual blood lancing device, single-use
Primary Device ID00384701027024
NIH Device Record Key8a9de395-b09e-402f-a690-8fbc21b08f61
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnistik 3
Version Model NumberAT 1027
Company DUNS217266915
Company NameOWEN MUMFORD LIMITED
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Dimensions

Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100384701027000 [Unit of Use]
GS100384701027017 [Primary]
GS100384701027024 [Package]
Contains: 00384701027017
Package: Sleeve [5 Units]
In Commercial Distribution
GS100384701027031 [Package]
Package: Case [20 Units]
In Commercial Distribution

FDA Product Code

FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-15
Device Publish Date2023-02-07

Devices Manufactured by OWEN MUMFORD LIMITED

00384701402036 - Unistik Touch2023-04-07 Unistik Touch contact activated safety lancets - 23G x 2.0mm - medium flow
00384701015038 - Unistik 2023-02-15 Unistik Safety Lancet Economy - 21G
00384701027024 - Unistik 32023-02-15Unistik 3 Safety Lancet Gentle - 30G
00384701027024 - Unistik 32023-02-15 Unistik 3 Safety Lancet Gentle - 30G
00384701614033 - Unistik Pro2023-02-15 Unistik Pro Safety Lancet - 21G x 2.0mm
00384701634031 - Unistik Pro2023-02-15 Unistik Pro Safety Lancet - 25G x 1.6mm
00384701644030 - Unistik Pro2023-02-15 Unistik Pro Safety Lancet - 28G x 1.2mm
00384701404030 - Unistik Touch - Contact Activated Safety Lancet - 23G x 2.0mm2021-04-12 Sterile, single use safety lancet
00384701412035 - Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm2021-04-12 Sterile, single use safety lancet

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