Disposable Instruments

FDA UDI

Class I (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name: Disposable Instruments FDA UDI
Generic Name: Ophthalmic working-channel cannula, single-use FDA UDI
Device Name: A/C Washout Cannula, 19g x 1”, 8mm Bend, Flattened, Bulk (Cardinal Healthcare), Bulk, Non-sterile FDA UDI
Model / Reference: B-4036-NSC FDA UDI
Description: A/C Washout Cannula, 19g x 1”, 8mm Bend, Flattened, Bulk (Cardinal Healthcare), Bulk, Non-sterile FDA UDI

Identifiers

Primary DI / UDI-DI: 20845819001596 FDA UDI
FDA Product Code: HMX FDA UDI
GMDN Term: Ophthalmic working-channel cannula, 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

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

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Manufacturing Date

FDA UDI

Category: Ophthalmic working-channel cannula, single-use

A sterile rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or high-grade stainless steel and enables the introduction of ophthalmic surgical instruments; it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during surgery). This is a single-use device.

Similar devices

Also classified as Ophthalmic working-channel cannula, single-use.

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Disposable Instruments — OASIS Medical, Inc. · Class I
Disposable Instruments — OASIS Medical, Inc. · Class I
Disposable Instruments — OASIS Medical, Inc. · Class I
Disposable Instruments — OASIS Medical, Inc. · Class I
Disposable Instruments — OASIS Medical, Inc. · 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 acb1fa94-70ec-4fbb-84bd-b206c10bd064 34 fields · synced Jul 8, 2026