AccessGUDID - DEVICE: Alcon AcrySof® (00380659909467)

GUDID

Device Identifier (DI) Information

Brand Name: Alcon AcrySof®
Version or Model: Version 3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380659909467
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: AcrySof® IQ Toric IOL Calculator

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:	No
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?
52847	Intraocular lens calculation software	A stand-alone software application designed to assist a surgeon in the selection and placement of an intraocular lens (IOL) by performing calculations to help predict the amount of postoperative corneal astigmatism that needs to be corrected. It is designed to be installed on an off-the-shelf computer/smart device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQL	intraocular lens

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: No
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: 0d3a82fc-6ed1-4969-8950-0c87bab08972
Public Version Date: December 22, 2021
Public Version Number: 4
DI Record Publish Date: December 13, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +18008625266
Email: web.masterus@alcon.com

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