FDA.report

SU-365

Primary DI
B145117451
Brand
SU-365
Company
OPTICAL INTEGRITY INC
Model
11743
Device description
365 micrometer laser fiber, single use, sterile
Published
2018-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B145117451PackageHIBCC5In Commercial Distribution
B145117430PrimaryHIBCC0

GMDN Terms

TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Outer Diameter365Micrometer

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius37 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
850-233-5512customercare@opticalintegrity.
850-233-5512customercare@opticalintegrity.com

Regulatory Flags

DUNS number
024050887
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00810077635735365 ForTec Thulium TFL Laser FiberFT-0365S-RT-00C-BLK-1118642021-07-06
00810077635742550 ForTec Thulium TFL Laser FiberFT-0550S-RT-00C-BLK-1118692021-07-06
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