SLA Standard (577 nm)

GUDID 00813125016982

for Haag Streit 900 BM/BQ Slit Lamp or equivalent

IRIDEX CORPORATION

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system

• Primary Device ID: 00813125016982
• NIH Device Record Key: 5519e2ff-b8f0-458f-bfcf-49eef5725b57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SLA Standard (577 nm)
• Version Model Number: 65512
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com
• Phone: (800) 388-4747
• Email: techsupport@iridex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813125016982 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-10
• Device Publish Date: 2024-05-02

Devices Manufactured by IRIDEX CORPORATION

• 00813125010584 - OMA (810 nm): 2024-05-14 OMA, 810nm, for Zeiss Visu 150/200 Operating Microscope
• 00813125010591 - OMA (810 nm): 2024-05-14 OMA, 810 nm, for Leica/Wild M650/M690 Operating Microscope
• 00813125010645 - OMA (810 nm): 2024-05-14 OMA, 810 nm, for OPMI-6 Operating Microscope
• 00813125016975 - SLA EasyView™ (577 nm): 2024-05-14 for Haag Streit 900 BM/BQ Slit Lamp
• 00813125016999 - SLA (577 nm): 2024-05-14 for Zeiss 30 slit lamp or equivalent
• 00813125017019 - SLA (532 nm): 2024-05-14 for Zeiss 30 CSO or equivalent
• 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