FDA UDI In Commercial Distribution 🇺🇸 United States

UltraPulse™ DUO

DI: 07290109147284 · Model: UltraPulse™ DUO · LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
UltraPulse™ DUO
Primary DI
07290109147284
Version / Model
UltraPulse™ DUO
Catalog Number
GA-2000000D
Company Name
LUMENIS LTD.
Labeler DUNS
600166524
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-09-19
Public Version
2
Public Version Date
2024-01-17
Public Version Status
Update
Public Device Record Key
5ccc9790-4bf3-4e3f-932a-c4b4c311c7de

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
17774 General/multiple surgical solid-state/carbon dioxide laser system

Identifiers

Type ID
Primary 07290109147284