MicroPulse® P3 Device Single

GUDID 00813125015251

IRIDEX CORPORATION

Ophthalmic laser system beam guide Ophthalmic laser system beam guide

• Primary Device ID: 00813125015251
• NIH Device Record Key: 2b73ad7e-b27c-448e-a9ea-1558928673b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroPulse® P3 Device Single
• Version Model Number: 15522-1
• Company DUNS: 612920785
• Company Name: IRIDEX CORPORATION
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125015251 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by IRIDEX CORPORATION

• 00813125010935 - SLA (810 nm): 2024-05-10 SLA, 810 nm, for Haag Streit w/MM Slit Lamp
• 00813125011147 - SLA EasyFit™ (532 nm): 2024-05-10 SLA EasyFit™, 532nm, for Zeiss 30 & Split-Mirror Slit Lamp
• 00813125011185 - SLA 50 µm (532 nm): 2024-05-10 SLA 50 µm, 532nm, for Haag Streit 900 BQ w/MM Slit Lamp
• 00813125011208 - SLA 50 µm (532 nm): 2024-05-10 SLA 50 µm, 532 nm, for Haag Streit 900BQ Slit Lamp
• 00813125016524 - SLA EasyView™ (532 nm): 2024-05-10 SLA EasyView™ , 532 nm, for Haag Streit BM/BQ CSO Slit Lamp
• 00813125016548 - SLA (810 nm): 2024-05-10 SLA, 810 nm, for Haag Streit 900 BM Slit Lamp
• 00813125016982 - SLA Standard (577 nm): 2024-05-10 for Haag Streit 900 BM/BQ Slit Lamp or equivalent
• 00813125017002 - SLA Standard (532 nm): 2024-05-10 for Haag Streit BM/BQ CSO or equivalent