FDA UDI In Commercial Distribution 🇺🇸 United States

LenSx, Alcon

DI: 10380659982252 · Model: 8065998225 · Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10

Basic Information

Brand Name
LenSx, Alcon
Primary DI
10380659982252
Version / Model
8065998225
Company Name
Alcon Laboratories, Inc.
Labeler DUNS
008018525
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2016-09-24
Public Version
6
Public Version Date
2023-11-03
Public Version Status
Update
Public Device Record Key
f857f6df-c3e8-4d16-90b3-274a4aefbb89

Device Description

LENSX LASER SOFTFIT PATIENT

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HQC Unit, phacofragmentation

GMDN Terms

Code Name
65747 Ophthalmic laser system eyeball positioning suction cup

Identifiers

Type ID
Primary 10380659982252
Package 20380659982259
Unit of Use 00380659982255