FDA UDI In Commercial Distribution 🇺🇸 United States

SS FiberLase™ Accessory Starter Kit with Endure Fiber

DI: 07290109142524 · Model: SS FiberLase™ Accessory Starter Kit with Endure Fiber · LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SS FiberLase™ Accessory Starter Kit with Endure Fiber
Primary DI
07290109142524
Version / Model
SS FiberLase™ Accessory Starter Kit with Endure Fiber
Company Name
LUMENIS LTD.
Labeler DUNS
600166524
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-14
Public Version
4
Public Version Date
2021-10-21
Public Version Status
Update
Public Device Record Key
d6f75c13-293f-454e-a3e5-419249d72b0b

Device Characteristics

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

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 07290109142524

Customer Contacts

Phone
408-764-3000