FDA UDI In Commercial Distribution 🇺🇸 United States

SPORTARREDO

DI: 08030389004643 · Model: LP2 USA · SPORTARREDO GROUP S.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
SPORTARREDO
Primary DI
08030389004643
Version / Model
LP2 USA
Company Name
SPORTARREDO GROUP S.C.
Labeler DUNS
435527116
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-22
Public Version
1
Public Version Date
2020-07-30
Public Version Status
New
Public Device Record Key
5d2b08b0-9d1f-42e2-9a55-8b87045dde49

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
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
Primary 08030389004643

Premarket Submissions

Submission Number Supplement Number
K161394 000