Alcon Custom-Pak

GUDID H5301ALCON1CPAK10

Alcon Custom-Pak

Alcon Laboratories, Inc.

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device IDH5301ALCON1CPAK10
NIH Device Record Key92119d7d-b650-4afb-b62f-ba580af5e4ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlcon Custom-Pak
Version Model NumberCPAK1
Company DUNS008018525
Company NameAlcon Laboratories, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com
Phone+18008625266
EmailWeb.masterus@alcon.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH5301ALCON1CPAK10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LROGeneral Surgery Tray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-24

On-Brand Devices [Alcon Custom-Pak]

H5302ALCON2CPAK20Alcon Custom-Pak
H5301ALCON1CPAK10Alcon Custom-Pak

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