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

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
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
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
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM S1.73182026-04-20
13700773731999STOPLOSS® JONES TUBE 3,5 X 19 MM S1.73192026-04-20
13700773732002STOPLOSS® JONES TUBE 3,5 X 20 MM S1.73202026-04-20

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Primary DI, Brand, Company table
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1081748902373720ga Curved Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-28
1081748902374420ga Curved Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-28
1081748902375120ga Curved Illuminated Laser Probe, 19ga Needle Illumination, DORCKATALYST SURGICAL LLCHQF2020-11-28
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1081748902378223ga Flexible Tapered Illuminated Laser Probe, Quantel CompatibleKATALYST SURGICAL LLCHQF2020-11-28
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