27GA Straight Laser Probe

FDA UDI

Class II (US FDA UDI)

by Peregrine Surgical, LLC.

Identity

Trade Name: 27GA Straight Laser Probe FDA UDI
Generic Name: Ophthalmic laser system beam guide FDA UDI
Device Name: 27GA Straight Laser Probe FDA UDI
Model / Reference: PD727.10DU FDA UDI
Description: 27GA Straight Laser Probe FDA UDI

Identifiers

Primary DI / UDI-DI: 00632307000881 FDA UDI
510(k) Number: K024061 FDA UDI
FDA Product Code: GEX FDA UDI
HQF FDA UDI
GMDN Term: Ophthalmic laser system beam guide FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
886.4390 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 27 Gauge FDA UDI

Category: Ophthalmic laser system beam guide

27GA Straight Laser Probe by Peregrine Surgical, LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ophthalmic laser system beam guide.

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Synergetics — SYNERGETICS USA, INC. · Class II
OtoProbe™ Short Angled Box of 6 — Iridex Corporation · Class II

Cleared under the same submission

K024061 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Peregrine Surgical, LLC.

Sources (1)

FDA UDI 246b1b22-7f56-4cbf-bddc-5ef57ab863ca 36 fields · synced Jun 6, 2026