25GA Straight Laser Probe, SMA905

GUDID 10632307001731

25GA Straight Laser Probe, SMA905

PEREGRINE SURGICAL, LTD.

Ophthalmic laser system beam guide

• Primary Device ID: 10632307001731
• NIH Device Record Key: 53ca6a65-1d1a-4adf-8ce4-5fa1cb219b2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25GA Straight Laser Probe, SMA905
• Version Model Number: GA-0040008
• 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: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com
• Phone: +1(215)348-0456
• Email: jayne@peregrine-surgical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 25 Gauge
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00632307001734 [Primary]
GS1	10632307001731 [Package]; Contains: 00632307001734; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024061

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

Ethylene Oxide

[10632307001731]

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 [25GA Straight Laser Probe, SMA905]

• 10632307002103: 25GA Straight Laser Probe, SMA905
• 10632307001731: 25GA Straight Laser Probe, SMA905