20GA Illuminating Laser Probe, SMA905

GUDID 10632307001755

20GA Illuminating Laser Probe, SMA905

PEREGRINE SURGICAL, LTD.

Ophthalmic laser system beam guide

• Primary Device ID: 10632307001755
• NIH Device Record Key: dc2d7a58-44c5-4d7a-9afc-0cda35cdd2b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 20GA Illuminating Laser Probe, SMA905
• Version Model Number: GA-0040010
• Company DUNS: 622467348
• Company Name: PEREGRINE SURGICAL, LTD.
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00632307001758 [Primary]
GS1	10632307001755 [Package]; Contains: 00632307001758; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031023

FDA Product Code

• HQF: Laser, ophthalmic

Sterilization

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

[10632307001755]

Ethylene Oxide

[10632307001755]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [20GA Illuminating Laser Probe, SMA905]

• 10632307002042: 20GA Illuminating Laser Probe, SMA905
• 10632307001946: 20GA Illuminating Laser Probe, SMA905
• 10632307001755: 20GA Illuminating Laser Probe, SMA905