FDA.reportPublic FDA data

23ga MultiFlex™ Extendable Laser Probe, Iridex Connector

Primary DI
10817489026615
Brand
23ga MultiFlex™ Extendable Laser Probe, Iridex Connector
Company
KATALYST SURGICAL LLC
Model
V6510E-23A
Device description
23ga MultiFlex™ Extendable Laser Probe, Iridex Connector
Published
2017-12-17
Public version status
Update
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
10817489026615PrimaryGS10
00817489026618Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081748902661510817489026615
00817489026618008174890266188174890266180817489026618

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.

Sterilization Methods#

Method table
Method

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
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsDNK8-15SDNK8-15S2026-10-08
0081748902541323ga DEX™ Morris ILM ForcepsDVF4033-23DVF4033-232026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsDVF4036-27DVF4036-272026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsDVF4036-23DVF4036-232026-10-07
0084009620361525ga DEX™ Yoneda Super Grip ForcepsDVF4036-25DVF4036-252026-10-07
0084009620509125ga DEX Stiff NanoTapered Awh ForcepsDVF4005-25-SDVF4005-25-S2026-10-07
0084009620510725ga DEX Stiff Morris Honey Badger ForcepsDVF4010-25-SDVF4010-25-S2026-10-07
0084009620511425ga DEX Stiff Asymmetrical Tano ForcepsDVF4014-25-SDVF4014-25-S2026-10-07
0084009620512125ga (0.50mm) Dex™ Stiff Serrated Jaw ForcepsDVF4016-25-SDVF4016-25-S2026-10-07
0084009620513825ga DEX Stiff Maculorhexis ForcepsDVF4019-25-SDVF4019-25-S2026-10-07
0084009620514525ga DEX Stiff End Grasper ForcepsDVF4022-25-SDVF4022-25-S2026-10-07
0084009620515225ga DEX Stiff Morris ILM ForcepsDVF4033-25-SDVF4033-25-S2026-10-07
0084009620516925ga DEX™ Stiff Super Grip ForcepsDVF4034-25-SDVF4034-25-S2026-10-07
0084009620518325ga DEX Stiff Curved Horizontal ScissorsDVS5006-25-SDVS5006-25-S2026-10-07
0084009620519025ga DEX Stiff Vertical ScissorsDVS5101-25-SDVS5101-25-S2026-10-07
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsDNK7-05SDNK7-05S2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsDNK7-10SDNK7-10S2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsDNK7-15SDNK7-15S2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsDNK8-05SDNK8-05S2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsDNK8-10SDNK8-10S2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
1084009621142623ga Multi-Flex™ Extendable Laser Probe, Quantel ConnectorKATALYST SURGICAL LLCHQA2020-03-25
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