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Disposable Instruments

FDA UDI

Class I (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name
Disposable Instruments FDA UDI
Generic Name
Ophthalmic surgical irrigation/infusion/aspiration handle, single-use FDA UDI
Device Name
Capsule Polisher, 21g x 7/8”, 6mm Bend FDA UDI
Model / Reference
4027B FDA UDI
Description
Capsule Polisher, 21g x 7/8”, 6mm Bend FDA UDI

Identifiers

Primary DI / UDI-DI
00845819001073 FDA UDI
FDA Product Code
HMX FDA UDI
GMDN Term
Ophthalmic surgical irrigation/infusion/aspiration handle, 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

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Ophthalmic surgical irrigation/infusion/aspiration handle, single-use

A comprehensive guide to Disposable Instruments, a medical device designed for ophthalmic surgical procedures. This article provides an overview of its features, regulatory compliance, and usage instructions.

Similar devices

Also classified as Ophthalmic surgical irrigation/infusion/aspiration handle, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OASIS Medical, Inc.

Sources (1)

  • FDA UDI 6256f821-522a-47b7-92dd-33cae8ea0e6f 34 fields · synced Jul 9, 2026