DEVICE: OtoLase™ Curved Tip Package (07290109142791)

Device Identifier (DI) Information

OtoLase™ Curved Tip Package
OtoLase™ Curved Tip Package
In Commercial Distribution

LUMENIS LTD.
07290109142791
GS1

1
600166524 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
17774 General/multiple surgical solid-state/carbon dioxide laser system
A mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one solid-state [e.g., neodymium-doped yttrium-aluminium-garnet (Nd:YAG)] mediated and the other carbon dixoide (CO2) mediated, intended for bloodless incisions during general surgery and/or multiple specialized surgical applications (non-dedicated). It is intended to provide both the cutting capabilities of gas mediated lasing, and the haemostatic abilities of solid-state mediated lasing. It includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include frequency doubling technology.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEX Powered Laser Surgical Instrument
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Curved Tip angle 10°
Lumen/Inner Diameter: 250 Micrometer
Outer Diameter: 700 Micrometer
Length: 65 Millimeter
CLOSE

Device Record Status

1a208d97-0b10-420f-a27e-0dab53bffebb
October 21, 2021
4
October 05, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
17290109142798 12 07290109142791 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
408-764-3000
xxx@xxx.xxx
CLOSE