Walcott Rx Products

FDA UDI

Class I (US FDA UDI)

by Walcott Rx Product Inc

Identity

Trade Name: Walcott Rx Products FDA UDI
Generic Name: Ophthalmic knife, reusable FDA UDI
Device Name: Chopper FDA UDI
Model / Reference: Rx4-538 FDA UDI
Description: Chopper FDA UDI

Identifiers

Primary DI / UDI-DI: 00840285310629 FDA UDI
FDA Product Code: HNQ FDA UDI
GMDN Term: Ophthalmic knife, reusable 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

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic knife, reusable

Walcott Rx Products is a trusted brand in the medical device industry, offering a range of innovative hand-held surgical instruments designed for precise ophthalmic surgery. Our flagship product, the Ophthalmic Knife (OHC), is a reusable chopper made from high-grade stainless steel with diamond blades. With its durable construction and sharp cutting edge, this instrument enables surgeons to make accurate incisions in delicate eye tissues during complex procedures.

Similar devices

Also classified as Ophthalmic knife, reusable.

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Mastel Precision Surgical Instruments, Inc. — MASTEL SURGICAL INC. · Class I
Mastel Precision Surgical Instruments, Inc. — MASTEL SURGICAL INC. · Class I
Ophthalmic Knife — Katena Products, Inc. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
Wexler Surgical, Inc. — Wexler Surgical, 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: Walcott Rx Product Inc

Sources (1)

FDA UDI ad76a87c-dc02-4fb6-9053-becf9e167912 34 fields · synced Jul 9, 2026