AgaMatrix Lancing Device

GUDID 00385540132504

AGAMATRIX, INC.

Manual blood lancing device, reusable
Primary Device ID00385540132504
NIH Device Record Keyae8ea95f-6371-4eea-8b62-f71a729e62a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAgaMatrix Lancing Device
Version Model Number8300-01325
Company DUNS156756129
Company NameAGAMATRIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com
Phone1-866-906-4197
Emailcustomerservice@agamatrix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100385540132504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-26
Device Publish Date2023-09-18

On-Brand Devices [AgaMatrix Lancing Device]

003855410622068300-10622
003855401325048300-01325

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