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
0081748902202325ga Dex™ Serrated Jaw ForcepsDVF4016-252016-08-11
0081748902214625ga Dex™ Maculorhexis ForcepsDVF4019-252016-08-11
00840096207606DEX TIPS™ Universal HandleCV-Handle2020-06-08
00840096207613DEX TIPS™ Universal Slim HandleCVO-Handle2020-06-08
10840096211365Cili Probes (Cyclophotocoagulation)6202312020-03-04
10817489025298Cyclophotocoagulation Probe, Quantel ConnectorXLCYCLO2018-12-11
10817489025304Cyclophotocoagulation Probe, Iridex ConnectorXLCYCLOA2018-12-11
10817489025151Ciliprobe Transsceral Cyclophotocoagulation ProbeD4700A2017-07-21
10817489025168Ciliprobe Transsceral Cyclophotocoagulation ProbeD4700C2017-07-21
1084009621532527ga Stiff Slim DEX™ NanoTapered™ Awh ForcepsDVFO4005-272025-10-06
00840096214987Curved Up Micro Scissors, 11mm Blades, Bayonet Round Handle, 230mmN61062025-09-10
1081748902356020ga Straight Illuminated Laser Probe, 19ga Needle Illumination, IridexV6300-20AR2020-11-25
1081748902357720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconV6300-20BR2020-11-27
1081748902358420ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelV6300-20CR2020-11-27
1081748902359120ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekV6300-20ER2020-11-27
1081748902360720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCV6300-20JR2020-11-27
1081748902361423ga Straight Illuminated Laser Probe, 19ga Needle Illumination, IridexV6300-23AR2020-11-25
1081748902362123ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconV6300-23BR2020-11-27
1081748902363823ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelV6300-23CR2020-11-27
1081748902364523ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekV6300-23ER2020-11-27

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