GUDID M735A5486005

OPHTHALMED LLC

Ophthalmic laser system beam guide

• Primary Device ID: M735A5486005
• NIH Device Record Key: 7384464d-7cf2-470c-864b-42dfb7826611
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: A548600
• Company DUNS: 791553436
• Company Name: OPHTHALMED LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com
• Phone: 7707776613
• Email: info@ophthalmed.com

Device Dimensions

• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge
• Needle Gauge: 20 Gauge

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M735A5486001 [Primary]
HIBCC	M735A5486005 [Package]; Contains: M735A5486001; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050807

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-30
• Device Publish Date: 2022-09-22

Devices Manufactured by OPHTHALMED LLC

• M735A5026005 - NA: 2022-09-30
• M735A5027005 - NA: 2022-09-30
• M735A5036005 - NA: 2022-09-30
• M735A5037005 - NA: 2022-09-30
• M735A5076005 - NA: 2022-09-30
• M735A5077005 - NA: 2022-09-30
• M735A5086005 - NA: 2022-09-30
• M735A5087005 - NA: 2022-09-30