FDA UDI In Commercial Distribution 🇺🇸 United States

OmniGuide RFID Surgical Fibers

DI: 04250341910599 · Model: 101 503 xxx · LISA Laser Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
OmniGuide RFID Surgical Fibers
Primary DI
04250341910599
Version / Model
101 503 xxx
Catalog Number
101 503 648
Company Name
LISA Laser Products GmbH
Labeler DUNS
315026396
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-01-23
Public Version
1
Public Version Date
2026-02-02
Public Version Status
New
Public Device Record Key
63afcc82-5930-4ec4-954e-dbdce89fb976

Device Description

LISA Laser Surgical Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. The key components of this system are the SMA-905, SMA-906 and Manufacturer’s specific connectors and the Fiber Optic

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
MR Safe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GEX Powered Laser Surgical Instrument

GMDN Terms

Code Name
61474 General/multiple surgical laser system beam guide, reusable

Identifiers

Type ID
Primary 04250341910599