Gilras

GUDID 00851158007188

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

Ophthalmic slit lamp, examination

• Primary Device ID: 00851158007188
• NIH Device Record Key: cf847d99-1f90-48ce-b73a-e21bf0d03c4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gilras
• Version Model Number: GR-54C/LL
• 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	00851158007188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080776

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 [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