FDA.reportPublic FDA data

Cryo Probe: Extended Retinal, 2.5mm

Primary DI
08717872021416
Brand
Cryo Probe: Extended Retinal, 2.5mm
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
1540.D
Catalog number
1540.D
Published
2017-07-12
Public version status
Update
Distribution status
Not 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
HRNUnit, Cryophthalmic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRNUnit, Cryophthalmic, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160591000D.O.R.C. Disposable Cryo ProbeDutch Ophthalmic Research Center International BV2017-01-23HRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717872021416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717872021416087178720214168717872021416

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic cryosurgical system, electronicAn assembly of mains electricity (AC-powered) devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal during an ophthalmic surgical procedure. The system typically includes an electronic control unit which controls the flow of cryogen contained in a connected cylinder, dedicated cryogen-cooled hand-held applicators (probes) to apply the cold to the tissue, a foot-switch, and interconnections. It is commonly used for cryopexy for retinal detachment, cataract extraction, and to treat glaucoma, trichiasis, and retinopathy of prematurity (ROP).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
407522184
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717872031804EVA Custom TDC Vitrectomy Pack VGPC Input 23G8523.4222021-06-11
08717872003221Universal silicone infusion line for 20 gauge/0.9 mm cannula system.1279.IA201279.IA202021-02-01
08717872003245Infusion line for 23G / 0.6 mm infusion cannula 1272.ERPP21279.P1279.P2021-02-01
08717872003993Disposable Backflush instrument, with extended silicone tip and active aspiratio1281.TDM1281.TDM2021-02-02
08717872004013Replacement backflush reservoir with active aspiration.1281.XD1281.XD2021-02-02
08717872004075MVR Blade 23-G, angled1282.D061282.D062021-02-09
08717872004099One step stiletto insertor.(23 gauge / 0.6 mm)1282.F061282.F062021-02-09
08717872007403Disposable keratoscope1420.D1420.D2023-09-14
08717872012339Crescent Knife, 2.25, 55°, bevel up51.111851.11182021-01-29
08717872012346Slit Knife, 2.2mm, angled 45°, bibevel51.372251.37222021-01-29
08717872012384MVR Blade 20G, straight51.523051.52302021-01-29
08717872015255Universal silicone infusion line for 20 gauge/0.9 mm cannula system, suitable fo1279.IA20S1279.IA20S2021-02-01
08717872015712MVR Blade 20G, angled52.522052.52202021-01-29
08717872015736Trapezoid Knife 1.2 x 1.4mm, angled53.121453.12142021-01-29
08717872015743Slit Knife, 2.2mm, angled, bevel up53.372253.37222021-01-29
08717872015750Slit Knife, 2.75mm, angled, bevel up53.372753.37272021-01-29
08717872015798Clear Corneal Knife, 2.5mm, angled54.572554.57252021-01-29
08717872015934Stab Knife, 15°51.489151.48912021-01-29
08717872031811EVA Custom TDC Vitrectomy Pack VGPC Input 25G8525.4098525.4012021-06-11
08717872031828EVA Custom TDC Vitrectomy Pack VGPC Input 27G8527.4068525.4012021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055272707503ADAPTOR FOR F SIZE CO2 CYLINDERKEELER LIMITEDHRN2025-03-26
05055272707527ADAPTOR FOR F SIZE N2O CYLINDERKEELER LIMITEDHRN2025-03-26
05055272721424DORC CRYOSTAR ADAPTORKEELER LIMITEDHRN2025-03-26
05055272721431ERBE ERBOKRYO ADAPTORKEELER LIMITEDHRN2025-03-26
05055272720113Single Use Retinal Cryo Probe (Box of 10 Probes)KEELER LIMITEDHRN2020-11-09
B564MVCY1000PHAKOSPHAKOSHRN2018-10-22
B564MVAD930PHAKOSPHAKOSHRN2018-10-03
B564MVAD94NG0PHAKOSPHAKOSHRN2018-10-03
B564MVAD95NG0PHAKOSPHAKOSHRN2018-10-03
B564MVAD96NG0PHAKOSPHAKOSHRN2018-10-03
B564MVAD97NG0PHAKOSPHAKOSHRN2018-10-03
B564MVAD98NG0PHAKOSPHAKOSHRN2018-10-03
B564MVAD99NG0PHAKOSPHAKOSHRN2018-10-03
10816340021066NeoDevices, Inc.NEODEVICES INCHRN2016-09-24
05055272707640Cryomatic 2.5mm Std Ret PencilKEELER LIMITEDHRN2016-08-16
050552727076572.5mm Extended Retinal PencilKEELER LIMITEDHRN2016-08-16
050552727076642.5mm Mid-Reach Retinal PencilKEELER LIMITEDHRN2016-08-16
050552727076710.89mm Intra-Vitreal PencilKEELER LIMITEDHRN2016-08-16
050552727076881.5mm Curved Cataract PencilKEELER LIMITEDHRN2016-08-16
050552727076953mm Glaucoma PencilKEELER LIMITEDHRN2016-08-16
050552727077014x10mm Collins Trichiasis PencilKEELER LIMITEDHRN2016-08-16
05055272711753Cryomatic MkII ConsoleKEELER LIMITEDHRN2016-08-16
05055272711760Cryomatic MkII Standard Retinal PencilKEELER LIMITEDHRN2016-08-16
050552727118142.5mm Extended Retinal PencilKEELER LIMITEDHRN2016-08-16
050552727118212.5mm Mid-Reach Retinal PencilKEELER LIMITEDHRN2016-08-16
050552727118380.89mm Intra Vitreal ProbeKEELER LIMITEDHRN2016-08-16
050552727118451.5mm Curved Cataract ProbeKEELER LIMITEDHRN2016-08-16
050552727118523mm Glaucoma ProbeKEELER LIMITEDHRN2016-08-16
050552727118694x10mm Collins Trichiasis PencilKEELER LIMITEDHRN2016-08-16
05055272716963Disposable Cryo Probes, Box of 10KEELER LIMITEDHRN2016-08-16