FDA.reportPublic FDA data

357 micron laser fiber

Primary DI
00810077631454
Brand
357 micron laser fiber
Company
OPTICAL INTEGRITY INC
Model
11949
Catalog number
11949
Device description
357-micron laser fiber, single use, sterile
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
00810077631454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077631454008100776314548100776314540810077631454

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-useA 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; a fibreoptic cable may be included with the device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter357Micrometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius37 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8502335512contact@opticalintegrity.com

Regulatory Flags#

DUNS number
024050887
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810077631461200 micron soft tip laser fiber11531115312025-08-29
00081007763051200 micron Soft Tip laser fiber11531115312025-05-20
00810077631447Stripper Scribe Tool113822025-04-11
00810077631430200 micron Excalibur DC laser fiber11952119522025-02-28
00810077631355300 micron laser fiber (KTP)11637116372024-08-09
00810077630594600 KTP Laser FiberOI-0600S-FT-000-AUR-1116392021-05-19
00810077631409300 micron laser fiber (KTP) with ScopeGuardian sheath119402024-09-24
00810077631393300 micron laser fiber (KTP) with ScopeGuardian sheath119402024-09-24
00810077631379300 micron laser fiber (KTP)119112024-09-06
00810077631362300 micron laser fiber (KTP)119112024-09-06
00810077631294SmartScopeSU-200-RT119202024-03-22
00810077631300SmartScopeSU-365-RT119222024-03-22
00810077631317SmartScopeSU-550-RT119232024-03-22
00810077631324SmartScopeSU-1000-RT119242024-03-22
00810077631331SmartScopeSU-200-TRUE-RT119192024-03-22
00810077630969SmartScopeSU-200-RT119202024-03-22
00810077630976SmartScopeSU-365-RT119222024-03-22
00810077630983SmartScopeSU-550-RT119232024-03-22
00810077630990SmartScopeSU-1000-RT119242024-03-22
00810077631348SmartScopeSU-200-TRUE-RT119192024-03-22

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Primary DI, Brand, Company table
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08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16