FDA.reportPublic FDA data

2.5mm Extended Retinal Pencil

Primary DI
05055272707657
Brand
2.5mm Extended Retinal Pencil
Company
KEELER LIMITED
Model
2509-P-8001
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K062412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062412000CRYOMATICKeeler Instruments, Inc.2006-11-06HRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055272707657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055272707657050552727076575055272707657

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
210164398
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055272711777PSL One3010-P-20012016-08-08
05055272707503ADAPTOR FOR F SIZE CO2 CYLINDER2508-P-70162025-03-26
05055272707527ADAPTOR FOR F SIZE N2O CYLINDER2508-P-70182025-03-26
05055272721424DORC CRYOSTAR ADAPTOR2509-P-80362025-03-26
05055272721431ERBE ERBOKRYO ADAPTOR2509-P-80372025-03-26
050552727199263.6V PROFESSIONAL OPHTH IN CASE1128-P-1014-5002020-02-27
050552727007643.6V PROFESSIONAL OPHTH HEAD ONLY1128-P-10042016-08-26
050552727007712.8V PROFESSIONAL OPHTH IN CASE1128-P-10132016-08-26
050552727007883.6V PROFESSIONAL OPHTH IN CASE1128-P-10142016-08-26
050552727009003.6V SPECIALIST OPHTH IN CASE1132-P-11572016-08-26
05055272701204API 2/2 IN CARTON1204-P-30362016-08-26
05055272701341API 2/2 Kit 11204-P-31002016-08-16
05055272702621POWER PACK IN CARTON (USA)1919-P-10022016-08-26
05055272702669POWER PACK ASSY1919-P-51192016-08-26
05055272702768LITHIUM MINI CHARGER IN CARTON1941-P-13412016-08-26
05055272702775LITHIUM DOUBLE CHARGER1941-P-13682016-08-26
05055272702782WIRELESS INDIRECT CHARGER IN CARTON1941-P-13842016-08-26
05055272702874SMARTPACK1945-P-10012016-08-26
05055272711241Vantage Plus Digital Kit1205-P-50102016-08-16
05055272711265Vantage Plus LED Slimline & Charger1205-P-10202016-08-16

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
B564MVAD99NG0PHAKOSPHAKOSHRN2018-10-03
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
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