FDA UDI Not in Commercial Distribution 🇺🇸 United States

Quanta 1320

DI: 08033945935948 · Model: PDMS00211 · QUANTA SYSTEM SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Quanta 1320
Primary DI
08033945935948
Version / Model
PDMS00211
Company Name
QUANTA SYSTEM SPA
Labeler DUNS
436045833
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-15
Public Version
6
Public Version Date
2025-05-22
Public Version Status
Update
Public Device Record Key
86091a87-1786-4c36-ad39-79a1e5cfb46e
Distribution End Date
2023-06-15

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GEX Powered Laser Surgical Instrument

GMDN Terms

Code Name
60341 General/multiple surgical diode laser system

Identifiers

Type ID
Primary 08033945935948