Eli Ezer

GUDID 00851158007317

U.S. OPHTHALMIC, L.L.C.

Ophthalmic slit lamp, examination

• Primary Device ID: 00851158007317
• NIH Device Record Key: 5fe2720e-94e4-43da-8f8f-6ce9af9a6cde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eli Ezer
• Version Model Number: ESL-700
• Company DUNS: 166760392
• Company Name: U.S. OPHTHALMIC, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851158007317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063416

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-17

On-Brand Devices [Eli Ezer]

• 00851158007577: Binocular Indirect Ophthalmoscope
• 00851158007560: Binocular Indirect Ophthalmoscope Head Battery
• 00851158007553: Screen Projector Ezer EDC-2600
• 00851158007546: Eli Ezer Perimeter EPR-3600
• 00851158007539: Eli Ezer Perimeter EPR-2600
• 00851158007522: Ezer Diagnosis Wall Unit, 3.5 Led Ophthalmoscope and Otoscope with Dispenser, C battery and AC p
• 00851158007515: Eli Ezer EZ-RET-2600/LL
• 00851158007508: Eli Ezer Retinoscope EZ-RET-2600/HL
• 00851158007423: Ophthalmoscope and Otoscope Diagnostic Set, 2 Pcs AA handle and Zipper Bag
• 00851158007416: Ophthalmoscope and Otoscope Diagnostic Set, 2 Pcs AA handle and Zipper Bag Halogen
• 00851158007409: Ezer Fiber Otoscope
• 00851158007393: Fiber Otoscope Set EZ-OTC-1800 LED
• 00851158007386: EZ-OPH-1800/LL
• 00851158007379: EZ-OPH-1800/HL
• 00851158007362: EZ-SPH-2600 Wall Mount Sphygmomanometers with Adult cuff
• 00851158007355: ESL-1200
• 00851158007348: ESL-1800
• 00851158007331: ESL-2600
• 00851158007324: ESL-5200
• 00851158007317: ESL-700
• 00851158007300: ESL-7800
• 00851158007294: ESL-9000C
• 00851158007287: EUS-2600
• 00851158007690: Non-mydriatic Auto Fundus Camera
• 00851158007706: Non-Contact Tonometer
• 00851158007782: Auto Ref Keratometer ERK-BH
• 00850038195236: Vison Screener EVS-1800
• 00850038195229: Hand Held Fundus Camera EFC-1800
• 00851158007683: ESL-Emerald-TN
• 00851158007669: ESL-Emerald-26
• 00851158007652: ESL-Emerald-12
• 00851158007645: ESL-Emerald-18
• 00851158007638: ESL-Emerald-8
• 00851158007621: ESL-Emerald-1
• 00850038195342: EZ-OPH-3600 ophthalmoscope LED Lamp
• 00850038195335: EZ-OPH-3600 ophthalmoscope HALOGEN Lamp
• 00851158007836: Digital Refractor Ezer EDR-9000 A
• 00851158007805: Digital Refractor Ezer EDR-H