Gilras

GUDID 00851158007454

GRK-6000 Autorefractor/Keratometer

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

Ophthalmic refractometer, automated Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer Automated ophthalmic refractometer

• Primary Device ID: 00851158007454
• NIH Device Record Key: 93545129-8fee-4943-94ba-7452b1293fb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gilras
• Version Model Number: GRK-6000
• Company DUNS: 166760392
• Company Name: U.S. OPHTHALMIC, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	00851158007454 [Primary]

FDA Product Code

• HKO: Refractometer, Ophthalmic

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: 2020-03-05
• Device Publish Date: 2016-11-22

On-Brand Devices [Gilras]

• 00851158007478: Gilras GR-1500 Manual Refractor
• 00851158007454: GRK-6000 Autorefractor/Keratometer
• 00851158007270: GR-36 2X/LL
• 00851158007263: GR-36 2X/HL
• 00851158007256: GR-36/HL
• 00851158007249: GR-36/LL
• 00851158007232: GR-36C/LL
• 00851158007225: GR-36C/HL
• 00851158007218: GR-54/LL
• 00851158007201: GR-54/HL
• 00851158007195: GR-54C/HL
• 00851158007188: GR-54C/LL
• 00851158007171: GR-54CCD/LL
• 00851158007164: GR-54CCD/HL
• 00851158007157: GR-7 2X/LL
• 00851158007140: GR-7 2X/HL
• 00851158007133: GR-7/HL
• 00851158007126: GR-7/LL
• 00851158007096: GRU-5000A
• 00851158007089: GRU-5000 A/P
• 00851158007072: GRU-5000P
• 00851158007065: GRU-6000
• 00851158007058: GRU-7000