AccessGUDID - DEVICE: UNIPURE & UNIFEYE (00380657530663)

GUDID

Device Identifier (DI) Information

Brand Name: UNIPURE & UNIFEYE
Version or Model: 8065753066
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8065753066
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380657530663
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System. Intraocular Gas Delivery System intended to treat uncomplicated retinal detachments.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44405	Perfluoropropane refillable cylinder	A container designed as a refillable cylinder used to hold compressed medical grade perfluoropropane (C3F8) under safe conditions at high pressure. It is filled with C3F8 when delivered from the gas/device supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote C3F8 content. It is made of steel or aluminium and must be used together with a pressure regulator in order to release the C3F8 at the correct working pressure. C3F8 is used predominately as a tamponade gas to aid the healing process from retinal surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPO	Gases Used Within Eye To Place Pressure On Detached Retina

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c7a790ae-bae5-47d5-9f20-d3bd1880cbce
Public Version Date: November 05, 2024
Public Version Number: 1
DI Record Publish Date: October 28, 2024