1st Tier Unilet

GUDID 00761059575009

1st Tier Unilet Lancets 30G

OWEN MUMFORD USA INCORPORATED

Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip
Primary Device ID00761059575009
NIH Device Record Key20bf4b67-6889-470b-bee0-41dd0f3b31f9
Commercial Distribution StatusIn Commercial Distribution
Brand Name1st Tier Unilet
Version Model NumberAT 0575FT
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count100
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 Latexfalse
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
Needle Gauge30 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100761059575009 [Unit of Use]
GS100761059575368 [Primary]

FDA Product Code

QRKSingle Use Only Blood Lancet Without 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 Date2023-04-07
Device Publish Date2023-03-30

On-Brand Devices [1st Tier Unilet]

007610595850081st Tier Unilet Lancets 33G
007610595750091st Tier Unilet Lancets 30G
007610595650001st Tier Unilet lancets 28G

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