FDA UDI In Commercial Distribution 🇺🇸 United States

FiberLase™ Endoscope Protection Sheath

DI: 07290109146614 · Model: FiberLase™ Endoscope Protection Sheath · LUMENIS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
FiberLase™ Endoscope Protection Sheath
Primary DI
07290109146614
Version / Model
FiberLase™ Endoscope Protection Sheath
Catalog Number
SA-1103020
Company Name
LUMENIS LTD.
Labeler DUNS
600166524
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-07-27
Public Version
1
Public Version Date
2022-08-04
Public Version Status
New
Public Device Record Key
3a1135d7-dc5e-44b0-90eb-185b4604a8a2

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
No
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
17774 General/multiple surgical solid-state/carbon dioxide laser system

Identifiers

Type ID
Primary 07290109146614
Package 17290109146611