FDA UDI In Commercial Distribution 🇺🇸 United States

WAVELIGHT REFRACTIVE SUITE

DI: 00380650001108 · Model: 8065000110 · Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
WAVELIGHT REFRACTIVE SUITE
Primary DI
00380650001108
Version / Model
8065000110
Company Name
Alcon Laboratories, Inc.
Labeler DUNS
008018525
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-02-24
Public Version
2
Public Version Date
2022-11-07
Public Version Status
Update
Public Device Record Key
025b1997-accb-408a-b169-1c7055d2f547

Device Description

STAND ALONE PATIENT BED

Device Characteristics

Single Use
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LZS Excimer laser system

GMDN Terms

Code Name
15723 Ophthalmic chair, line-powered

Identifiers

Type ID
Primary 00380650001108