UNIPURE & UNIPEXY 8065753069

GUDID 10380657530691

UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.

Alcon Laboratories, Inc.

Sulfur hexafluoride refillable cylinder
Primary Device ID10380657530691
NIH Device Record Keyee2ecb7c-b20e-4485-adb2-a18b58bcc10f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIPURE & UNIPEXY
Version Model Number8065753069
Catalog Number8065753069
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100380657530694 [Primary]
GS110380657530691 [Package]
Contains: 00380657530694
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

LPOGases Used Within Eye To Place Pressure On Detached Retina

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-05
Device Publish Date2024-10-28

On-Brand Devices [UNIPURE & UNIPEXY]

10380657530691UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System i
10380657530684UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery System. Intraocular Gas Delivery System

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