PurCel Labs Safety Lancets Push-Button (30G x 1.5mm)

GUDID 00810143550146

LANCET, PUSH-BTN SFTY, AUTO RETRACT, 30G NDL 1.5MM, FIXED DEPTH, LIGHT GREEN (100/BX)

Purcel Labs LLC

Blood lancet, single-use
Primary Device ID00810143550146
NIH Device Record Key0a4e892a-422e-4c99-8751-3cef7d15a845
Commercial Distribution StatusIn Commercial Distribution
Brand NamePurCel Labs Safety Lancets Push-Button (30G x 1.5mm)
Version Model Number1100-100
Company DUNS127672531
Company NamePurcel Labs LLC
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810143550139 [Primary]
GS100810143550146 [Package]
Contains: 00810143550139
Package: Case [20 Units]
In Commercial Distribution
GS110810143550136 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMKSingle Use Only Blood Lancet With 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 Date2023-08-02
Device Publish Date2023-07-25

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