Disposable Instruments

FDA UDI

Class I (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name: Disposable Instruments FDA UDI
Generic Name: Ophthalmic needle, single-use FDA UDI
Device Name: Peribulbar Needle (Atkinson Point) 25g x 1-1/4" (0.5 x 32mm) FDA UDI
Model / Reference: 4004M FDA UDI
Description: Peribulbar Needle (Atkinson Point) 25g x 1-1/4" (0.5 x 32mm) FDA UDI

Identifiers

Primary DI / UDI-DI: 00845819000779 FDA UDI
FDA Product Code: GAA FDA UDI
GMDN Term: Ophthalmic needle, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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 needle, single-use

Disposable Instruments by OASIS Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
OMNI Edge Surgical System — Sight Sciences, Inc. · Class II
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Walcott Rx Products — Psi/Eye-Ko, 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 d5b4a594-73d0-4f84-a328-390031ca5ed5 34 fields · synced Jun 9, 2026