FDA.reportPublic FDA data

3.6V SPECIALIST OPHTH IN CASE

Primary DI
05055272719933
Brand
3.6V SPECIALIST OPHTH IN CASE
Company
KEELER LIMITED
Model
1132-P-1157-500
Published
2020-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKLRetinoscope, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKLRetinoscope, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893172000VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)Keeler Instruments, Inc.1989-06-05HLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055272719933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055272719933050552727199335055272719933

GMDN Terms#

Term, Definition table
TermDefinition
Direct ophthalmoscope, line-poweredA mains electricity (AC-powered), hand-held, ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see the details of the retina and other structures/media (cornea, aqueous, lens, and vitreous). It consists of, a built-in light that is directed by the examiner through the pupil to illuminate the interior of the eyeball, a mirror with a single hole through which the examiner will view, and a dial containing several lenses of different powers that can be alternated by the examiner whilst viewing. It produces an upright, or unreversed, image of approximately 15 times magnification. The power is run through a transformer to reduce this to low-voltage.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
210164398
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
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
06945095540342zumaxZumax Medical Co., LTDHKL2026-05-20
06945095543923zumaxZumax Medical Co., LTDHKL2026-05-20
06945095544333zumaxZumax Medical Co., LTDHKL2026-05-20
00812559012249OptochekPlusREICHERT, INC.HKL2025-08-12
050552727199263.6V PROFESSIONAL OPHTH IN CASEKEELER LIMITEDHKL2020-02-27
050552727199403.6V PROFESSIONAL STREAK RETINOSCOPE IN CASEKEELER LIMITEDHKL2020-02-27
050552727199573.6V PROFESSIONAL STREAK LED RETINOSCOPE IN CASEKEELER LIMITEDHKL2020-02-27
05055272719964US PROFESSIONAL LED STUDENT KIT-SLIMKEELER LIMITEDHKL2020-02-27
05055272719971US PROFESSIONAL COMPLETE LED STUDENT SETKEELER LIMITEDHKL2020-02-27
050552727199883.6V PRACTITIONER/ FIBRE-OPTIC DIAGNOSTIC SETKEELER LIMITEDHKL2020-02-27
05055272719995SLIMLINE RECHARGEABLE HANDLE & BATTERYKEELER LIMITEDHKL2020-02-27
05055272720007RECHARGEABLE HANDLE & REFRACTION STAND ADAPTORKEELER LIMITEDHKL2020-02-27
05055272720038US LED SPECIALIST/ RETINOSCOPE STUDENT SETKEELER LIMITEDHKL2020-02-27
06945095531203zumaxZumax Medical Co., LTDHKL2018-07-31
06945095531302zumaxZumax Medical Co., LTDHKL2018-05-24
050552727007712.8V PROFESSIONAL OPHTH IN CASEKEELER LIMITEDHKL2016-08-26
050552727007883.6V PROFESSIONAL OPHTH IN CASEKEELER LIMITEDHKL2016-08-26
050552727008942.8V SPECIALIST OPHTH IN CASEKEELER LIMITEDHKL2016-08-26
050552727009003.6V SPECIALIST OPHTH IN CASEKEELER LIMITEDHKL2016-08-26
050552727015633.6V PROF STREAK RET HEAD ONLYKEELER LIMITEDHKL2016-08-26
050552727015702.8V PROFESSIONAL SPOT RET & CASEKEELER LIMITEDHKL2016-08-26
050552727015873.6V PROFESSIONAL SPOT RET & CASEKEELER LIMITEDHKL2016-08-26
050552727015942.8V PROFESSIONAL STREAK RET & CASEKEELER LIMITEDHKL2016-08-26
050552727016003.6V PROFESSIONAL STREAK RET & CASEKEELER LIMITEDHKL2016-08-26
05055272701662US PROF STUDENT KIT (SLIM HANDLE)KEELER LIMITEDHKL2016-08-26
050552727016792.8V STREAK RET & PROF OPHTHKEELER LIMITEDHKL2016-08-26
050552727016863.6V STREAK RET & PROF OPHTHKEELER LIMITEDHKL2016-08-26
050552727017162.8V STREAK RET & SPECIALIST OPHTHKEELER LIMITEDHKL2016-08-26
050552727017302.8V SPOT RET & SPECIALIST OPHTHKEELER LIMITEDHKL2016-08-26
050552727128733.6V PROFESSIONAL STREAK LED HEADKEELER LIMITEDHKL2016-08-26