FDA.reportPublic FDA data

PHAKOS

Primary DI
B564MVAD99NG0
Brand
PHAKOS
Company
PHAKOS
Model
MV AD 99 NG
Catalog number
MV AD 99 NG
Device description
Adapter Keeler ACU/CTU used with PHAKOS Disposable Retinal Cryo Probe
Published
2018-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K162756000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162756000PHAKOS Disposable Retinal Cryo ProbePhakos2017-05-03HRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B564MVAD99NG0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, mechanicalAn assembly of 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. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
401106299
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B564MVAS100PHAKOSMV AS 10MV AS 102019-01-16
B564MVLV40HR0PHAKOSMV LV 40 HRMV LV 40 HR2019-01-16
B564MVLV410PHAKOSMV LV 41MV LV 412019-01-16
B564MVLV41HR0PHAKOSMV LV 41 HRMV LV 41 HR2019-01-16
B564MVLV420PHAKOSMV LV 42MV LV 422019-01-16
B564MVLV42HR0PHAKOSMV LV 42 HRMV LV 42 HR2019-01-16
B564MVLV430PHAKOSMV LV 43MV LV 432019-01-16
B564MVLV43HR0PHAKOSMV LV 43 HRMV LV 43 HR2019-01-16
B564MVLV450PHAKOSMV LV 45MV LV 452019-01-16
B564MVLV45HR0PHAKOSMV LV 45 HRMV LV 45 HR2019-01-16
B564MVLV460PHAKOSMV LV 46MV LV 462019-01-16
B564MVLV470PHAKOSMV LV 47MV LV 472019-01-16
B564MVLV480PHAKOSMV LV 48MV LV 482019-01-16
B564MVLV48HR0PHAKOSMV LV 48 HRMV LV 48 HR2019-01-16
B564MVLV490PHAKOSMV LV 49MV LV 492019-01-16
B564MVLV500PHAKOSMV LV 50MV LV 502019-01-16
B564MVLV510PHAKOSMV LV 51MV LV 512019-01-16
B564MVLV520PHAKOSMV LV 52MV LV 522019-01-16
B564MVLV530PHAKOSMV LV 53MV LV 532019-01-16
B564MVLV540PHAKOSMV LV 54MV LV 542019-01-16

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
08717872021416Cryo Probe: Extended Retinal, 2.5mmD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HRN2017-07-12
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