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”, 4mm Bend (GTIN: 00845819001455) 1 eaches of Capsulorhexis Cystotome, Formed, 27g x 5/8”, 90 degree Tip (GTIN: 00845819004876) 1 eaches of A/C Washout Cannula, 19g x 1”, 8mm Bend, Flattened (GTIN: 00845819001516) 1 eaches of Hydrodissection Cannula, 25g x 7/8", 8mm Bend (GTIN: 00845819001516) FDA UDI
Model / Reference: SCK 2002, B-SCK 2002 FDA UDI
Description: Kit Packs Assembled from Non-Sterile Capped Product: 2 eaches of Anterior Chamber Cannula, 27g x 7/8”, 4mm Bend (GTIN: 00845819001455) 1 eaches of Capsulorhexis Cystotome, Formed, 27g x 5/8”, 90 degree Tip (GTIN: 00845819004876) 1 eaches of A/C Washout Cannula, 19g x 1”, 8mm Bend, Flattened (GTIN: 00845819001516) 1 eaches of Hydrodissection Cannula, 25g x 7/8", 8mm Bend (GTIN: 00845819001516) FDA UDI

Identifiers

Primary DI / UDI-DI: 00845819006313 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

Surgeon's Choice Card by OASIS Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: OASIS Medical, Inc.

Sources (1)

FDA UDI a0260258-317f-4b04-8721-80fe3cfda0bb 34 fields · synced Jun 9, 2026