25GA Wide Angle Light Pipe - Universal

GUDID 10632307001397

25GA Wide Angle Light Pipe - Universal

PEREGRINE SURGICAL, LTD.

Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 10632307001397
• NIH Device Record Key: 3bb9d265-ac1e-4b2f-9fbb-1398f72b9e9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25GA Wide Angle Light Pipe - Universal
• Version Model Number: PD125.14
• 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	00632307001390 [Primary]
GS1	10632307001397 [Package]; Contains: 00632307001390; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980025

FDA Product Code

• MPA: Endoilluminator

Sterilization

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

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

[10632307001397]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-05-06

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