GUDID M735B5643045

OPHTHALMED LLC

Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide Ophthalmic laser system beam guide

• Primary Device ID: M735B5643045
• NIH Device Record Key: 4b11943b-4311-451b-b42c-469d45336583
• Commercial Distribution Discontinuation: 2022-08-12
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: B564304
• 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

Device Dimensions

• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M735B5643041 [Primary]
HIBCC	M735B5643045 [Package]; Contains: M735B5643041; Package: [10 Units]; Discontinued: 2022-08-12; Not 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-08-15
• Device Publish Date: 2016-09-24

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