FDA.reportPublic FDA data

XLEND23MULTIFLEX

Primary DI
10840096215301
Brand
XLEND23MULTIFLEX
Company
KATALYST SURGICAL LLC
Model
XLEND23MULTIFLEX
Device description
MULTIFLEX LASER PROBE 23ga Quantel Compatible
Published
2025-06-24
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
true

Product Codes#

Code, Name table
CodeName
HQBPhotocoagulator And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQBPhotocoagulator And AccessoriesOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121187000KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBESKatalyst Surgical, LLC2012-09-17HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840096215301PackageGS110In Commercial Distribution
00840096215304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084009621530110840096215301
00840096215304008400962153048400962153040840096215304

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007883297
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
1084009621334527ga Stiff MultiFlex Inverted Extendable Laser Probe, Iridex ConnectorV6520E-27A2020-10-27
1084009621335227ga Stiff MultiFlex Inverted Extendable Laser Probe, Alcon ConnectorV6520E-27B2020-10-27
1084009621336927ga Stiff MultiFlex Inverted Extendable Laser Probe, Quantel ConnectorV6520E-27C2020-10-27
1084009621337627ga Stiff MultiFlex Inverted Extendable Laser Probe, Nidek ConnectorV6520E-27E2020-10-27
1084009621338327ga Stiff MultiFlex Inverted Extendable Laser Probe, Dorc ConnectorV6520E-27J2020-10-27
1084009621395625ga Illuminated MultiFlex™ Laser Probe, DORC ConnectorV6351-25JR2021-01-07
0084009620650023ga ISOCLEAN™ Micro Tying Forceps Gold3850S-M23G2020-05-27
0084009620676023ga ISOCLEAN™ Curved Iridectomy Scissors, Straight Shaft, Gold6850C-M23G2020-06-01
00840096208276Revolver Universal ConnectorRLP-A2020-06-08
00840096208283Constellation Illumination AdapterRLP-Q2020-06-10
00840096208290Stellaris Illumination AdapterRLP-S2020-06-10
00840096208306DORC Illumination AdapterRLP-U2020-06-10
00840096208313Short 19ga Needle Illumination AdapterRLP-V2020-06-10
0084009621284623ga ISOCLEAN™ Curved Iridectomy Scissors, Straight Shaft6850C-M232020-06-18
00840096207613DEX TIPS™ Universal Slim HandleCVO-Handle2020-06-08
10817489024536Revolver FiberV66002019-07-17
10817489024833Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 5DKIF7-05S2017-03-22
10817489024840Disposable Bipolar Focused Irrigating Forceps, 7", 1.0mm Straight Tips, Box of 5DKIF7-10S2017-03-22
10817489024857Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5DKIF7-15S2017-03-22
10817489024864Disposable Bipolar Focused Irrigating Forceps, 8", 0.5mm Straight Tips, Box of 5DKIF8-05S2017-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773703743FLEX CURVED LASER PROBE COMPATIBLE WITH Iridex / Bausch & Lomb™ 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773703750FLEX CURVED LASER PROBE COMPATIBLE WITH Alcon® / Coherent / Zeiss / Ellex / OS4®FCI S A S FCI 20 22HQB2021-05-30
13700773703767CURVED LASER PROBE, 27G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773703774FLEX CURVED LASER PROBE COMPATIBLE WITH NIDEK THREAD 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773703781FLEX CURVED LASER PROBE COMPATIBLE WITH DORC 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773720047STRAIGHT LASER PROBE, 20G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720054STRAIGHT LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720061STRAIGHT LASER PROBE, 20G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720078STRAIGHT LASER PROBE, 20G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720085STRAIGHT LASER PROBE, 20G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720092STRAIGHT LASER PROBE, 23G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720108STRAIGHT LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720115STRAIGHT LASER PROBE, 23G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720122STRAIGHT LASER PROBE, 23G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720139STRAIGHT LASER PROBE, 23G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720146STRAIGHT LASER PROBE, 25G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720153STRAIGHT LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720160STRAIGHT LASER PROBE, 25G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720177STRAIGHT LASER PROBE, 25G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720184STRAIGHT LASER PROBE, 25G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720191STRAIGHT LASER PROBE, 27G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720207STRAIGHT LASER PROBE, 27G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720214STRAIGHT LASER PROBE, 27G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720221STRAIGHT LASER PROBE, 27G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720238STRAIGHT LASER PROBE, 27G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720245CURVED LASER PROBE, 20G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720252CURVED LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720269CURVED LASER PROBE, 20G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720276CURVED LASER PROBE, 20G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720283CURVED LASER PROBE, 20G DORCFCI S A S FCI 20 22HQB2021-05-30