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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 sterile, hand held, manual surgical instrument constructed as a one piece handle and scalpel 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
PARAGON No. 23 NON STERILE DISPOSABLE SCALPELS FDA UDI
Description
A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalpel 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
PC10 FDA UDI
Primary DI / UDI-DI
05033955140106 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Swann-Morton Limited

Sources (1)

  • FDA UDI 42520056-a6fe-48ef-b366-34093bdadcc9 36 fields · synced Jun 1, 2026