Monofilament, Fine

GUDID 10632307002189

Monofilament, Fine

PEREGRINE SURGICAL, LTD.

Ophthalmic fibreoptic light instrument, single-use Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 10632307002189
• NIH Device Record Key: 2aa3f224-7e4e-4c3c-a53b-7f5e2531466f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monofilament, Fine
• Version Model Number: PD100.06
• 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: 215-348-0456
• Email: jayne@peregrine-surgical.com
• Phone: 215-348-0456
• Email: jayne@peregrine-surgical.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00632307002182 [Primary]
GS1	10632307002189 [Package]; Contains: 00632307002182; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980797

FDA Product Code

• MPA: Endoilluminator

Sterilization

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

[10632307002189]

Ethylene Oxide

[10632307002189]

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: 2017-01-10

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• 10632307001472 - 20GA Flexible 41GA Cannula: 2019-10-07 20GA Flexible 41GA Cannula