Unistik 3 Normal 23G

GUDID 00384701003011

Sterile, single use safety lancet

OWEN MUMFORD LIMITED

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Primary Device ID00384701003011
NIH Device Record Key6dfb63be-8c69-423e-8df7-6d94e44f98d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnistik 3 Normal 23G
Version Model NumberAT 1003
Company DUNS217266915
Company NameOWEN MUMFORD LIMITED
Device Count1000
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-Countertrue

Customer Support Contacts

Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com
Phone770-977-2226
Emailuscustomerservice@owenmumford.com

Device Dimensions

Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge
Depth1.8 Millimeter
Needle Gauge23 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100384701002007 [Unit of Use]
GS100384701003004 [Unit of Use]
GS100384701003011 [Primary]

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 Date2020-01-08
Device Publish Date2019-12-31

Devices Manufactured by OWEN MUMFORD LIMITED

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00384701015038 - Unistik 2023-02-15 Unistik Safety Lancet Economy - 21G
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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