FDA.reportPublic FDA data

CHANDELIER 25G

Primary DI
13700773700292
Brand
CHANDELIER 25G
Company
FCI S A S FCI 20 22
Model
S9.2301.25
Device description
CHANDELIER 25G
Published
2021-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQBPhotocoagulator And Accessories
HQFLaser, Ophthalmic
MPAEndoilluminator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQBPhotocoagulator And AccessoriesOphthalmic2
HQFLaser, OphthalmicOphthalmic2
MPAEndoilluminatorGastroenterology, Urology2

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
23700773700299PackageGS110In Commercial Distribution
13700773700292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2370077370029923700773700299
1370077370029213700773700292

Regulatory Flags#

DUNS number
763408366
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700773737113MACKOOL™ HOOKS (1X5)S8.51512026-11-02
13700773728067PRELOADED PUNCTAL PLUG (MINI US) - J.A. BERNARDS2.36722026-10-08
03760087120066Lacrimal punctum plugREADY-SET PUNCTUM PLUG (MINI, US 0.7)S2.3672u2020-02-25
13700773729644IRIS RETRACTOR 5 HOOKSS9.50152026-07-09
13700773731906TearSaver® - 0.4 mmS2.38422026-07-09
13700773731913TearSaver® - 0.5 mmS2.38522026-07-09
13700773736994TearSaver® - 0.8 mmS2.38822026-07-09
13700773737007Snug plugS2.4002U2026-07-09
23700773728705PRELOADED PERFORATED PLUG PVP - J.A. BERNARDS1.35122026-07-09
23700773728712PRELOADED MINI PERFORATED PLUG PVP - J.A. BERNARDS1.35222026-07-09
13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM S1.73092026-04-20
13700773729668STOPLOSS® JONES TUBE 3,5 X 10 MM S1.73102026-04-20
13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM S1.73112026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM S1.73122026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM S1.73132026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET S1.75002026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM S1.73142026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM S1.73152026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM S1.73162026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM S1.73172026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840096215304XLEND23MULTIFLEXKATALYST SURGICAL LLCHQB2025-06-24
00840096215304XLEND23MULTIFLEXKATALYST SURGICAL LLCHQF2025-06-24
00840096215304XLEND23MULTIFLEXKATALYST SURGICAL LLCMPA2025-06-24
10840096211075Illuminated Laser Probe, OS4, StraightKATALYST SURGICAL LLCHQF2023-06-07
1084009621395625ga Illuminated MultiFlex™ Laser Probe, DORC ConnectorKATALYST SURGICAL LLCMPA2021-01-07
1084009621334527ga Stiff MultiFlex Inverted Extendable Laser Probe, Iridex ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621335227ga Stiff MultiFlex Inverted Extendable Laser Probe, Alcon ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621336927ga Stiff MultiFlex Inverted Extendable Laser Probe, Quantel ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621337627ga Stiff MultiFlex Inverted Extendable Laser Probe, Nidek ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621338327ga Stiff MultiFlex Inverted Extendable Laser Probe, Dorc ConnectorKATALYST SURGICAL LLCHQF2020-10-27
00840096208283Constellation Illumination AdapterKATALYST SURGICAL LLCMPA2020-06-10
00840096208290Stellaris Illumination AdapterKATALYST SURGICAL LLCMPA2020-06-10
00840096208306DORC Illumination AdapterKATALYST SURGICAL LLCMPA2020-06-10
00840096208313Short 19ga Needle Illumination AdapterKATALYST SURGICAL LLCMPA2020-06-10
00840096208276Revolver Universal ConnectorKATALYST SURGICAL LLCMPA2020-06-08
1084009621123520ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621124223ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621125925ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621126627ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621127323ga Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621128025ga Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621129727ga Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621130320ga Illuminated Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621131023ga Illuminated Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621132725ga Illuminated Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621133427ga Illuminated Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621134123ga Illuminated Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621135825ga Illuminated Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
10817489024536Revolver FiberKATALYST SURGICAL LLCHQF2019-07-17
1081748902767425ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex ConnectorKATALYST SURGICAL LLCHQB2019-04-03