Unistik 2 Comfort - 28G

GUDID 00384700747039

Sterile, single use safety lancet

OWEN MUMFORD LIMITED

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Primary Device ID00384700747039
NIH Device Record Key320cd429-e805-4fc4-b01c-d220abbf13c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnistik 2 Comfort - 28G
Version Model NumberAT 0747
Company DUNS217266915
Company NameOWEN MUMFORD LIMITED
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-Countertrue

Customer Support Contacts

Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com
Phone770 977 2226
Emailus.info@owenmumford.com

Device Dimensions

Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 Gauge
Depth1.8 Millimeter

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
GS100384700742003 [Unit of Use]
GS100384700747015 [Primary]
GS100384700747039 [Package]
Contains: 00384700747015
Package: Case [20 Units]
In Commercial Distribution

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 Date2020-04-24
Device Publish Date2020-04-16

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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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