Surgeon's Choice Card

FDA UDI

Class I (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name: Surgeon's Choice Card FDA UDI
Generic Name: Ophthalmic cannulation set, single-use FDA UDI
Device Name: Kit Packs Assembled from Non-Sterile Capped Product: 2 eaches of Anterior Chamber Cannula, 27g x 7/8'', 8mm Bend (GTIN:00845819001448) 1 eaches Hydrodissection Cannula, 27g x 3/4'', 1mm Bend(GTIN:00845819001530) 1 eaches Irrigating Cystotome, 25g x 5/8", Reverse Formed (GTIN:00845819000977) FDA UDI
Model / Reference: SCK 2009, B-SCK 2009 FDA UDI
Description: Kit Packs Assembled from Non-Sterile Capped Product: 2 eaches of Anterior Chamber Cannula, 27g x 7/8'', 8mm Bend (GTIN:00845819001448) 1 eaches Hydrodissection Cannula, 27g x 3/4'', 1mm Bend(GTIN:00845819001530) 1 eaches Irrigating Cystotome, 25g x 5/8", Reverse Formed (GTIN:00845819000977) FDA UDI

Identifiers

Primary DI / UDI-DI: 00845819002971 FDA UDI
FDA Product Code: PZG FDA UDI
GMDN Term: Ophthalmic cannulation set, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Ophthalmic cannulation set, single-use

The Surgeon's Choice Card is a single-use ophthalmic cannulation set designed for posterior segment ophthalmic surgery, featuring two anterior chamber cannulas, hydrodissection cannula, and irrigating cystotome. This device provides precise control and minimizes complications, making it an ideal solution for surgeons in need of this specific procedure.

Similar devices

Also classified as Ophthalmic cannulation set, single-use.

Disposable One Step Cannula System (25 gauge/0.5 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
MANI Trocar Kit — MANI, INC. · Class I
ALCON — Alcon Laboratories, Inc. · Class I
23G Cannula set with High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
Disposable one step single cannula including inserter. (27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
25G High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
Alcon — Alcon Laboratories, Inc. · Class II
Infusion line for 23G / 0.6 mm infusion cannula 1272.ERPP2 — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: OASIS Medical, Inc.

Sources (1)

FDA UDI 9df56585-7cb3-469d-abeb-c45bccb2a68a 34 fields · synced Jul 9, 2026