FDA.reportPublic FDA data

Xplume 9611 Smoke Evacuation Secondary Filter

Primary DI
07290109142722
Brand
Xplume 9611 Smoke Evacuation Secondary Filter
Company
LUMENIS LTD.
Model
Xplume 9611 Smoke Evacuation Secondary Filter
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109142722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109142722072901091427227290109142722

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state/carbon dioxide laser systemA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408-764-3000xxx@xxx.xxx

Regulatory Flags#

DUNS number
600166524
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109147161Lumenis Pulse 120HLumenis Pulse 120HGA-0006800D2022-09-18
07290109147178Lumenis Pulse 120HLumenis Pulse 120HGA-0006801D2022-09-18
07290109147185Lumenis Pulse, Moses 2.0 (DOM)Lumenis Pulse, Moses 2.0 (DOM)GA-0006802D2022-09-18
07290109147192Lumenis Pulse 120HLumenis Pulse 120HGA-0006900D2022-09-18
07290109147208Lumenis Pulse, Moses 2.0 (INT)Lumenis Pulse, Moses 2.0 (INT)GA-0006902D2022-09-18
07290109147215Lumenis Pulse 120HLumenis Pulse 120HGA-0008700D2022-09-18
07290109147222Lumenis Pulse 120HLumenis Pulse 120HGA-0008800D2022-09-18
07290109147291Lumenis Pulse 120HLumenis Pulse 120HGA-2003476D2022-09-18
07290109147307Lumenis Pulse 120HLumenis Pulse 120HGA-2003477D2022-09-18
07290118853701Lumenis Pulse 60H, 60HzLumenis Pulse 60H, 60HzGA-2006379D2023-12-10
07290109144924Stellar SapphireCool LG 6mmStellar SapphireCool LG 6mm2019-08-06
07290109144931Stellar SapphireCool LG 15x35Stellar SapphireCool LG 15x352019-08-06
07290109144948Stellar SapphireCool LG 8x15Stellar SapphireCool LG 8x152019-08-06
07290109146676SurgiTouch Scanner SurgiTouch Scanner SPN-10287802022-09-22
07290109146133UltraPulse® DUOUltraPulse DUORG-20000002022-09-20
07290109147055VersaPulse PowerSuite 80/100WVersaPulse PowerSuite 80/100W0638-800-00D2022-09-19
07290109147062VersaPulse PowerSuite 80/100WVersaPulse PowerSuite 80/100W0638-800-01D2022-09-19
07290109147079VersaPulse PowerSuite 100WVersaPulse PowerSuite 100W0638-803-00D2022-09-19
07290109147086VersaPulse PowerSuite 100WVersaPulse PowerSuite 100W0638-803-01D2022-09-19
07290109147093VersaPulse PowerSuite 60WVersaPulse PowerSuite 60W0638-804-01D2022-09-19

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