AccessGUDID - DEVICE: Multiflex (00380652536431)

GUDID

Device Identifier (DI) Information

Brand Name: Multiflex
Version or Model: MTA5U0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MTA5U0.225
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380652536431
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: MULTIFLEX(TM*)III SINGLE-PIECE PMMASTERILE ACL (IOL/AC), 13.5mm LENGTH, 5.5mmCONVEXOPLANO OPTIC, 0.5mm VAULTED HAPTICS. *REG. U.S. PAT. & TM OFF.

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":	No
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Anterior-chamber intraocular lens, pseudophakic	An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the region of the eye posterior of the cornea and anterior of the iris (anterior chamber) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is typically made of a synthetic polymer.

FDA Product Code

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Product Code	Product Code Name
HQL	intraocular lens

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P880087	002

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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Diopter 22.5

Device Record Status

Public Device Record Key: a6f26700-454f-4fe7-93d5-b0511679ed58
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015