LuxVision

GUDID 00851158007003

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

Ophthalmic slit lamp, examination

• Primary Device ID: 00851158007003
• NIH Device Record Key: f3d23f7e-999d-42a1-b44a-c6d3d2ad6646
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LuxVision
• Version Model Number: SL-1100
• 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	00851158007003 [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: 2016-08-16

On-Brand Devices [LuxVision]

• 00851158007119: TN-180B
• 00851158007102: TN-150B
• 00851158007041: SL-880
• 00851158007034: SL-700
• 00851158007027: SL-2000
• 00851158007010: SL-1400
• 00851158007003: SL-1100
• 00851158007720: Ophthalmic Refraction unit RU-1000