Ciliprobe Transsceral Cyclophotocoagulation Probe

Primary DI
10817489025168
Brand
Ciliprobe Transsceral Cyclophotocoagulation Probe
Company
KATALYST SURGICAL LLC
Model
D4700C
Device description
Quantel connector
Published
2017-07-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQJLens, Surgical, Laser, Accesssory, Ophthalmic LaserOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163632000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163632000Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLC2017-06-15LQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817489025168PrimaryGS10
00081748902516Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081748902516810817489025168
00081748902516000817489025160817489025160081748902516

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
5
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
10840096211365Cili Probes (Cyclophotocoagulation)KATALYST SURGICAL LLCLQJ2020-03-04
00840096211368Cili Probes (Cyclophotocoagulation)KATALYST SURGICAL LLCLQJ2020-03-04
10817489025298Cyclophotocoagulation Probe, Quantel ConnectorKATALYST SURGICAL LLCLQJ2018-12-11
10817489025304Cyclophotocoagulation Probe, Iridex ConnectorKATALYST SURGICAL LLCLQJ2018-12-11
10817489025151Ciliprobe Transsceral Cyclophotocoagulation ProbeKATALYST SURGICAL LLCLQJ2017-07-21