AccessGUDID - DEVICE: LenSx® SoftFit™ (00380659982750)

GUDID

Device Identifier (DI) Information

Brand Name: LenSx® SoftFit™
Version or Model: 8065998275
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380659982750
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: LenSx® SoftFit™ Patient Interface Steep

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65747	Ophthalmic laser system eyeball positioning suction cup	A non-powered device intended to orient and fix the eyeball in a desired position relative to an ophthalmic laser system beam guide during ophthalmic laser surgery. It is designed as a laser-interfacing suction cup intended to contact and stabilize the eyeball via suction controlled by the laser system; it may also include a treatment contact lens. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQC	Unit, phacofragmentation

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: 3747c7bb-be35-4e41-b722-01cdd7a3a3f8
Public Version Date: November 03, 2023
Public Version Number: 5
DI Record Publish Date: August 31, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20380659982754	60	00380659982750		In Commercial Distribution

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)862-5266
Email: web.masterus@alcon.com

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