Unistik 3 - Comfort 28G

GUDID 00384701042034

Sterile, single use safety lancet

OWEN MUMFORD LIMITED

Manual blood lancing device, single-use Manual blood lancing device, single-use
Primary Device ID00384701042034
NIH Device Record Key632295f5-863a-4b7d-8af4-bcb7410d0b16
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnistik 3 - Comfort 28G
Version Model NumberAT1042
Company DUNS217266915
Company NameOWEN MUMFORD LIMITED
Device Count100
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

Device Dimensions

Needle Gauge28 Gauge
Depth1.8 Millimeter
Needle Gauge28 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100384701042003 [Unit of Use]
GS100384701042010 [Primary]
GS100384701042034 [Package]
Contains: 00384701042010
Package: Case [40 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 - Comfort 28G]

00384701044038Sterile, single use safety lancet
00384701042034Sterile, single use safety lancet

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