FDA.reportPublic FDA data

MaxiFlex Holmium Laser Fiber

Primary DI
B324MF400BH0
Brand
MaxiFlex Holmium Laser Fiber
Company
MAXIFLEX, LLC
Model
MF 400BH
Device description
365 micron Holmium Laser Fiber with SMA 905 connector for Lumenis lasers.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013300000MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEMTechnology Delivery Systems, Inc.2002-04-16GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B324MF400BH0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital surgical laser system beam guide, single-useA sterile, flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas); it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter550Micrometer

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
198887072
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B324MF1000BH0MaxiFlex Holmium Laser Fiber MF 1000BH 2016-09-24
B324MF1000BHC0MaxiFlex Holmium Laser Fiber MF 1000BH C2016-09-24
B324MF1000BHD0MaxiFlex Holmium Laser Fiber MF 1000BH D2016-09-24
B324MF1000BHN0MaxiFlex Holmium Laser Fiber MF 1000BH N2016-09-24
B324MF1000BHT0MaxiFlex Holmium Laser Fiber MF 1000BH T2016-09-24
B324MF200BHHPX0MaxiFlex Holmium Laser Fiber MF 200BH HPX2016-09-24
B324MF200BHHPXC0MaxiFlex Holmium Laser Fiber MF 200BH HPX C2016-09-24
B324MF200BHHPXD0MaxiFlex Holmium Laser Fiber MF 200BH HPX D2016-09-24
B324MF200BHHPXN0MaxiFlex Holmium Laser Fiber MF 200BH HPX N2016-09-24
B324MF200BHHPXT0MaxiFlex Holmium Laser Fiber MF 200BH HPX T2016-09-24
B324MF400BHC0MaxiFlex Holmium Laser Fiber MF 400BH C2016-09-24
B324MF400BHD0MaxiFlex Holmium Laser Fiber MF 400BH D2016-09-24
B324MF400BHN0MaxiFlex Holmium Laser Fiber MF 400BH N2016-09-24
B324MF400BHT0MaxiFlex Holmium Laser Fiber MF 400BH T2016-09-24
B324MF600BH0MaxiFlex Holmium Laser Fiber MF 600BH 2016-09-24
B324MF600BHC0MaxiFlex Holmium Laser Fiber MF 600BH C2016-09-24
B324MF600BHD0MaxiFlex Holmium Laser Fiber MF 600BH D2016-09-24
B324MF600BHN0MaxiFlex Holmium Laser Fiber MF 600BH N2016-09-24
B324MF600BHT0MaxiFlex Holmium Laser Fiber MF 600BH T2016-09-24
B324MF1000BHCR0MaxiFlex Holmium Laser Fiber MF 1000BH C R2016-09-24

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