FDA.reportPublic FDA data

23ga Multi-Flex™ Extendable Laser Probe, Quantel Connector

Primary DI
10840096211426
Brand
23ga Multi-Flex™ Extendable Laser Probe, Quantel Connector
Company
KATALYST SURGICAL LLC
Model
V6510E-23C
Device description
23ga Multi-Flex™ Extendable Laser Probe, Quantel Connector
Published
2020-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQAUnit, Cryotherapy, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQAUnit, Cryotherapy, OphthalmicOphthalmic2

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
10840096211426PrimaryGS10
00840096211429Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084009621142610840096211426
00840096211429008400962114298400962114290840096211429

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fibreoptic light instrument, single-useA sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.

Regulatory Flags#

DUNS number
007883297
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817489027483Laser Probe OS4, MultiFlex, 23gaVK4003032019-03-19
10817489027490Laser Probe OS4, MultiFlex, 25gaVK4003052019-03-19
10817489027506Laser Probe OS4, MultiFlex Inverted, 23gaVK4003132019-03-19
10817489027513Laser Probe OS4, MultiFlex Inverted, 25gaVK4003152019-03-19
10817489027520Laser Probe OS4, MultiFlex Extendable, 23gaVK4003232019-03-19
10817489027544Laser Probe OS4, MultiFlex Inverted Extendable, 23gaVK4003332019-03-19
10817489027551Laser Probe OS4, MultiFlex Inverted Extendable, 25gaVK4003352019-03-19
1084009621123520ga Straight Laser Probe6202002020-03-04
1084009621124223ga Straight Laser Probe6202012020-03-04
1084009621125925ga Straight Laser Probe6202022020-03-04
1084009621126627ga Straight Laser Probe6202032020-03-04
1084009621127323ga Flexible Curved Laser Probe6202102020-03-04
1084009621128025ga Flexible Curved Laser Probe6202112020-03-04
1084009621129727ga Flexible Curved Laser Probe6202122020-03-04
1084009621130320ga Illuminated Straight Laser Probe6202202020-03-04
1084009621131023ga Illuminated Straight Laser Probe6202212020-03-04
1084009621132725ga Illuminated Straight Laser Probe6202222020-03-04
1084009621133427ga Illuminated Straight Laser Probe6202232020-03-04
1084009621134123ga Illuminated Flexible Curved Laser Probe6202292020-03-04
1084009621135825ga Illuminated Flexible Curved Laser Probe6202302020-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
1081748902661523ga MultiFlex™ Extendable Laser Probe, Iridex ConnectorKATALYST SURGICAL LLCHQA2017-12-17
00888937019896TrichiasisCoopersurgical, Inc.HQA2017-09-27
00888937009422FrigitronicsCoopersurgical, Inc.HQA2016-08-02
00888937004052FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004069FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004076FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004083Frigitronics Coopersurgical, Inc.HQA2016-07-20
00888937004090FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004106FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004113FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004120FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004137FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004144FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004151FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004168FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004175FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004182FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004199FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004205FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004212FrigitronincsCoopersurgical, Inc.HQA2016-07-20
00888937004229FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004236FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004243FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004250FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004267FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004274FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004281FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004298FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004304FrigitronicsCoopersurgical, Inc.HQA2016-07-20
00888937004311FrigitronicsCoopersurgical, Inc.HQA2016-07-20