FDA UDI In Commercial Distribution 🇺🇸 United States

SUPRA - SUN ITALIA

DI: G619370010 · Model: SI-0650PIX · JW NORTH AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
SUPRA - SUN ITALIA
Primary DI
G619370010
Version / Model
SI-0650PIX
Catalog Number
37001
Company Name
JW NORTH AMERICA, INC.
Labeler DUNS
039280558
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-08-01
Public Version
1
Public Version Date
2024-08-09
Public Version Status
New
Public Device Record Key
b69e5d55-fce0-4ad5-80f8-420066a26acd

Device Description

Ultraviolet tanning device

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LEJ Booth, Sun Tan

GMDN Terms

Code Name
46387 Ultraviolet tanning device

Identifiers

Type ID
Package G619370011
Primary G619370010
Previous B5331143870