FDA.reportPublic FDA data

Eli Ezer

Primary DI
00851158007683
Brand
Eli Ezer
Company
U.S. OPHTHALMIC, L.L.C.
Model
ESL-Emerald-TN
Device description
ESL-Emerald-TN
Published
2024-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKXTonometer, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851158007683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851158007683008511580076838511580076830851158007683

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, manualAn ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This device (known as a contact type, e.g., a Schioetz or Perkins tonometer) is used in the diagnosis of glaucoma and may be hand-held or used in conjunction with a slit lamp.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
166760392
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850038195564EZ-TRI-3600EZ-TRI-36002025-02-19
00850038195557LuxVsionLDR-7800LDR-78002024-04-08
00851158007805Eli EzerEDR-H2024-04-08
00851158007836Eli EzerEDR-9000 A2024-04-08
00850038195335Eli EzerEZ-OPH-3600-Halogen-Lamp2024-04-03
00850038195342Eli EzerEZ-OPH-3600- Led Lamp2024-04-03
00851158007621Eli EzerESL-Emerald-12024-01-25
00851158007638Eli EzerESL-Emerald-82024-01-25
00851158007645Eli EzerESL-Emerald-182024-01-25
00851158007652Eli EzerESL-Emerald-122024-01-25
00851158007669Eli EzerESL-Emerald-262024-01-25
00851158007003LuxVisionSL-11002016-08-16
00851158007010LuxVisionSL-14002016-08-16
00851158007027LuxVisionSL-20002016-08-16
00851158007034LuxVisionSL-7002016-08-16
00851158007041LuxVisionSL-8802016-08-16
00851158007126GilrasGR-7/LL2016-08-17
00851158007133GilrasGR-7/HL2016-08-17
00851158007140GilrasGR-7 2X/HL2016-08-17
00851158007157GilrasGR-7 2X/LL2016-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719872711230MiiSMEDIMAGING INTEGRATED SOLUTION INC.HKX2026-04-29
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06430033851920iCare ST500ICARE FINLAND OYHKX2025-12-05
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONHKX2025-11-17
07350023774307CalcibonBiomet Biologics, LLCHKX2025-10-09
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKX2025-03-11
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
06430033851784ST500 SmartCradleICARE FINLAND OYHKX2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKX2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKX2024-11-07
06430033851883iCare ST500ICARE FINLAND OYHKX2024-11-07
04547451026686INAMI INAMI & CO., LTD.HKX2023-07-27
04547451026709INAMIINAMI & CO., LTD.HKX2023-07-27
03615020000458WAVE ANALYZER MEDICA 800ESSILOR INTERNATIONALHKX2023-07-25
08800019600411Applanation Tonometer HT-5000Huvitz Co., Ltd.HKX2023-06-12
08800019600435Non-contact Tonometer HNT-1PHuvitz Co., Ltd.HKX2023-06-12
08800019600558Auto Tono/Refracto/Kerato/Pachymeter HTR-1AHuvitz Co., Ltd.HKX2023-06-12
03664188000145Visionix VX650LUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000923RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000930RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
04047844051269DIPLOMAT Def.SIGNUS Medizintechnik GmbHHKX2022-06-20
04047844051276DIPLOMAT Def.SIGNUS Medizintechnik GmbHHKX2022-06-20
04582273600263NON-CONTACT TONOMETERTOMEY CORPORATION.HKX2022-04-01
00851158007706Eli EzerU.S. OPHTHALMIC, L.L.C.HKX2021-01-04
M6333974340JEDMEDJEDMED INSTRUMENT COMPANYHKX2020-09-01
03664188000039VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKX2020-05-25
03664188000046VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKX2020-05-25
03664188000909VISIONIXLUNEAU TECHNOLOGY OPERATIONSHKX2020-05-25