FDA.reportPublic FDA data

Dornier Thulio Performance Fiber

Primary DI
10816959021884
Brand
Dornier Thulio Performance Fiber
Company
INNOVAQUARTZ LLC
Model
200um Reusable Fiber
Catalog number
K2016369
Published
2025-04-24
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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180140000ProFlex Laser FibersInnovaquartz, LLC2018-04-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816959021884PackageGS13In Commercial Distribution
00816959021887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081695902188410816959021884
00816959021887008169590218878169590218870816959021887

GMDN Terms#

Term, Definition table
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; a fibreoptic cable may be included with the device. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
844-776-3539info@proflexfibers.com

Regulatory Flags#

DUNS number
079295103
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816959021924Dornier Thulio Performance Fiber200 micron Ball Tip Single UseK20163672026-04-21
00816959021931Dornier Thulio Performance Fiber270um Ball Tip Single UseK20163682026-04-21
00816959021948MegaJOULE LDD™HaloFiber Radial Delivery Device 660HFRDD6602026-04-21
00816959021955MegaJOULE LDD™DragonFiber Lateral Delivery Device 660DFLDD6602026-04-21
00816959021627MegaJOULE LDD™MegaJOULE Lateral Delivery Device 660MJLDD6602021-07-22
00816959021870Dornier Thulio Performance Fiber200um Single-Use FiberK20163602025-04-24
00816959021887Dornier Thulio Performance Fiber200um Reusable FiberK20163692025-04-24
10816959021877Dornier Thulio Performance Fiber200um Single-Use FiberK20163602025-04-24
00816959021672ProFlex™ 273 Reusable Laser Lithotripsy Fiber var. TrimedynR-LLF273TG-T-USL2020-08-18
00816959021696ProFlex™365 Reusable Laser Lithotripsy Fiber var. TrimedynR-LLF365-T-USL2020-08-18
00816959021719ProFlex™550 Reusable Laser Lithotripsy Fiber var. TrimedynR-LLF550-T-USL2020-08-18
00816959021733ProFlex™910 Reusable Laser Lithotripsy Fiber var. TrimedynR-LLF910-T-USL, R-LLF1000-T-USL2020-08-18
00816959021634ProFlex™ 200 Reusable Laser Lithotripsy FiberR-LLF200LT-USL2020-08-17
00816959021641ProFlex™200 Reusable Laser Lithotripsy Fiber var. TrimedynR-LLF200TG-T-USL2020-08-17
00816959021658ProFlex™200 Reusable Laser Lithotripsy FiberR-LLF200TG-USL2020-08-17
00816959021665ProFlex™273 Reusable Laser Lithotripsy FiberR-LLF273LT-USL2020-08-17
00816959021689ProFlex™ 273 Reusable Laser Lithotripsy FiberR-LLF273TG-USL2020-08-17
00816959021702ProFlex™365 Reusable Laser Lithotripsy FiberR-LLF365-USL2020-08-17
00816959021726ProFlex™550 Reusable Laser Lithotripsy FiberR-LLF550-USL2020-08-17
00816959021740ProFlex™910 Reusable Laser Lithotripsy FiberR-LLF910-USL, R-LLF1000-USL2020-08-17

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Primary DI, Brand, Company table
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