27GA Curved Illuminating Laser Probe - Iridex

GUDID 10632307002349

27GA Curved Illuminating Laser Probe - Iridex

Peregrine Surgical, Llc

Ophthalmic laser system beam guide

• Primary Device ID: 10632307002349
• NIH Device Record Key: 2d432fec-4571-4f6e-b375-159700b2ee08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 27GA Curved Illuminating Laser Probe - Iridex
• Version Model Number: 7627.IRI-00
• Company DUNS: 622467348
• Company Name: Peregrine Surgical, Llc
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: ryan@peregrine-surgical.com

Device Dimensions

• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 27 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00632307002342 [Primary]
GS1	10632307002349 [Package]; Contains: 00632307002342; Package: Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132614

FDA Product Code

• HQB: PHOTOCOAGULATOR AND ACCESSORIES

Sterilization

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

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

[10632307002349]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-02
• Device Publish Date: 2024-09-24

Devices Manufactured by Peregrine Surgical, Llc

• 10632307002325 - 27GA Curved Illuminating Laser Probe - DORC: 2024-10-02 27GA Curved Illuminating Laser Probe - DORC
• 00632307002335 - 27GA Curved Illuminating Laser Probe - Alcon: 2024-10-02 27GA Curved Illuminating Laser Probe - Alcon
• 10632307002349 - 27GA Curved Illuminating Laser Probe - Iridex: 2024-10-0227GA Curved Illuminating Laser Probe - Iridex
• 10632307002349 - 27GA Curved Illuminating Laser Probe - Iridex: 2024-10-02 27GA Curved Illuminating Laser Probe - Iridex
• 10632307002356 - 25GA Midfield Endoillumination Probe: 2024-10-02 25GA Midfield Endoillumination Probe
• 10632307002363 - 27GA Midfield Endoillumination Probe: 2024-10-02 27GA Midfield Endoillumination Probe
• 10632307002370 - 23GA Midfield Endoillumination Probe: 2024-10-02 23GA Midfield Endoillumination Probe
• 10632307002264 - 23GA Straight Pick: 2024-09-11 23GA Straight Pick