FDA.reportPublic FDA data

SLH 5XC LED Di TBL

Primary DI
05055272715171
Brand
SLH 5XC LED Di TBL
Company
KEELER LIMITED
Model
3020-P-2010
Published
2016-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055272715171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055272715171050552727151715055272715171

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
210164398
Device count
1
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
0695109080097866VT66 VISION TECH CO., LTD.HJO2026-04-27
04250668607202VISUREF 600Carl Zeiss Vision GmbHHJO2026-04-24
04049471097153SL 220Carl Zeiss Meditec AGHJO2026-01-13
00852194002137SL-5000Hightech American Industrial Labs IncHJO2025-12-18
04547451338321INAMIINAMI & CO., LTD.HJO2025-08-29
00819034023240TalarLiftFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520738PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520745PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520752PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520769PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520776PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520783PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520790PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520806IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520813IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520820LapiLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520837DynaBridgeFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520844DynaBridgeFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520851Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520868Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520875LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520882Sgarlato SilasticFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520905PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520912PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520929PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520936PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00852164007346Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00852164007353Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
04987646810476KOWA SL-19KOWA COMPANY,LTD.HJO2024-10-08
04560323640940MARCOTAKAGI SEIKO CO.,LTD.HJO2024-03-14