Swann Morton Ltd. PC03

GUDID 05063043140039

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.

SWANN-MORTON LIMITED

Scalpel, single-use
Primary Device ID05063043140039
NIH Device Record Key9d66dc21-2688-4881-8d69-6edef5bd1a16
Commercial Distribution StatusIn Commercial Distribution
Brand NameSwann Morton Ltd.
Version Model NumberPARAGON No. 11 NON STERILE DISPOSABLE SCALPELS
Catalog NumberPC03
Company DUNS212397483
Company NameSWANN-MORTON LIMITED
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401142344231
Emailinfo@swann-morton.com
Phone+4401142344231
Emailinfo@swann-morton.com
Phone+4401142344231
Emailinfo@swann-morton.com
Phone+4401142344231
Emailinfo@swann-morton.com
Phone+4401142344231
Emailinfo@swann-morton.com
Phone+4401142344231
Emailinfo@swann-morton.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105033955140038 [Primary]
GS105063043140039 [Unit of Use]

FDA Product Code

GDXScalpel, One-Piece

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05063043140039]

Radiation Sterilization


[05063043140039]

Radiation Sterilization


[05063043140039]

Radiation Sterilization


[05063043140039]

Radiation Sterilization


[05063043140039]

Radiation Sterilization


[05063043140039]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-07
Device Publish Date2022-05-30

On-Brand Devices [Swann Morton Ltd.]

05063043023332A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043023325A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043023318A sterile, hand held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043022038Dermatome. A surgical instrument used for harvesting skin for grafting purposes.
05063043022014Dermatome. A surgical instrument used for harvesting skin for grafting purposes.
05063043021024Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043020010Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019854Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019847Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019830Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019823Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019816Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019809Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019700Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019694Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019670Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019663Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019649Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019632Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019625Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019403Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019311Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019304Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019298Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019274Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019236Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019229Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019106Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019038Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019021Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043019014Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043007288Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043007271Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043007264Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043007240Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043007233Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043007219Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be
05063043005925A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005918A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005390A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005277A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005260A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005253A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005246A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005239A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005222A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005215A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005208A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005192A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b
05063043005185A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel b

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.