Swann Morton Ltd.

FDA UDI

Class I (US FDA UDI)

by Swann-Morton Limited

Identity

Trade Name: Swann Morton Ltd. FDA UDI
Generic Name: Scalpel, single-use FDA UDI
Device Name: A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device. FDA UDI
Model / Reference: No. 15 NON STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD FDA UDI
Description: A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device. FDA UDI

Identifiers

Catalog Number: 3505 FDA UDI
Primary DI / UDI-DI: 05033955035051 FDA UDI
FDA Product Code: GDX FDA UDI
GMDN Term: Scalpel, 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Scalpel, single-use

Swann Morton Ltd. by Swann-Morton Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Scalpel, single-use.

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Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
Stylus — Surgical Specialties México, S. de R.L. de C.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

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Manufacturer

Manufacturer: Swann-Morton Limited

Sources (1)

FDA UDI d7f7cd40-e23c-4cee-a9c1-0bbfb83415e3 35 fields · synced May 30, 2026