Unistik 3 Extra - 21G

GUDID 00384701018039

Sterile, single use safety lancet

OWEN MUMFORD LIMITED

Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use
Primary Device ID00384701018039
NIH Device Record Key62474d19-ca0e-4d9f-9741-333b2b067150
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnistik 3 Extra - 21G
Version Model NumberAT 1018
Company DUNS217266915
Company NameOWEN MUMFORD LIMITED
Device Count25
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
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com
Phone770-977-2226
Emailinfo.us@owenmumford.com

Device Dimensions

Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 Millimeter
Needle Gauge21 Gauge
Depth2 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
GS100384701012006 [Unit of Use]
GS100384701018008 [Unit of Use]
GS100384701018015 [Primary]
GS100384701018039 [Package]
Contains: 00384701018015
Package: Case [100 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 Date2019-09-20
Device Publish Date2019-09-12

On-Brand Devices [Unistik 3 Extra - 21G]

00384701018039Sterile, single use safety lancet
00384701014031Sterile, single use safety lancet
00384701012037Sterile, single use safety lancet
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.