FDA.reportPublic FDA data

Swann Morton Ltd.

Primary DI
05063043040117
Brand
Swann Morton Ltd.
Company
SWANN-MORTON LIMITED
Model
No. 24 BULK NON STERILE RETRACTABLE SCALPELS
Catalog number
4011
Device description
A sterile, 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.
Published
2022-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDXScalpel, One-Piece

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05033955040116PrimaryGS10
05063043040117Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033955040116050339550401165033955040116
05063043040117050630430401175063043040117

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA 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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4401142344231info@swann-morton.com

Regulatory Flags#

DUNS number
212397483
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05063043023264Swann-Morton LimitedSTITCH CUTTER BULK NON STERILE DISPOSABLE SCALPELS23262025-08-25
05063043035045Swann Morton Ltd.No. 12 NON STERILE DISPOSABLE SCALPEL WITH RETRACT35042024-12-27
05063043036042Swann Morton Ltd.No. 12 STERILE DISPOSABLE SCALPEL WITH RETRACTING 36042024-12-27
05063043035014Swann Morton Ltd.No. 10 BULK NON STERILE DISPOSABLE SCALPEL WITH RE35012024-10-15
05063043035038Swann Morton Ltd.No. 11 NON STERILE DISPOSABLE SCALPEL WITH RETRACT35032024-10-15
05063043035052Swann Morton Ltd.No. 15 NON STERILE DISPOSABLE SCALPEL WITH RETRACT35052024-10-15
05063043035069Swann Morton Ltd.No. 20 NON STERILE DISPOSABLE SCALPEL WITH RETRACT35062024-10-15
05063043035076Swann Morton Ltd.No. 21 NON STERILE DISPOSABLE SCALPEL WITH RETRACT35072024-10-15
05063043035083Swann Morton Ltd.No. 22 NON STERILE DISPOSABLE SCALPEL WITH RETRACT35082024-10-15
05063043035106Swann Morton Ltd.No. 23 NON STERILE DISPOSABLE SCALPEL WITH RETRACT35102024-10-15
05063043035113Swann Morton Ltd.No. 24 NON STERILE DISPOSABLE SCALPEL WITH RETRACT35112024-10-15
05063043035267Swann Morton Ltd.STITCH CUTTER NON STERILE DISPOSABLE SCALPEL WITH 35262024-10-15
05063043035915Swann Morton Ltd.No. 11P NON STERILE DISPOSABLE SCALPEL WITH RETRAC35912024-10-15
05063043036011Swann Morton Ltd.No. 10 STERILE DISPOSABLE SCALPEL WITH RETRACTING 36012024-10-15
05063043036035Swann Morton Ltd.No. 11 STERILE DISPOSABLE SCALPEL WITH RETRACTING 36032024-10-15
05063043036059Swann Morton Ltd.No. 15 STERILE DISPOSABLE SCALPEL WITH RETRACTING 36052024-10-15
05063043036066Swann Morton Ltd.No. 20 STERILE DISPOSABLE SCALPEL WITH RETRACTING 36062024-10-15
05063043036073Swann Morton Ltd.No. 21 STERILE DISPOSABLE SCALPEL WITH RETRACTING 36072024-10-15
05063043036080Swann Morton Ltd.No. 22 STERILE DISPOSABLE SCALPEL WITH RETRACTING 36082024-10-15
05063043036103Swann Morton Ltd.No. 23 STERILE DISPOSABLE SCALPEL WITH RETRACTING 36102024-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850069257030LumohsNANO SURGICAL, INCGDX2026-02-20
36945630141820STERiLANCESterilance Medical (Suzhou) Inc.GDX2026-02-05
00850057092998HexaHexa DentalGDX2026-01-21
36945630137588index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137595index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137601index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137618index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630139063index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630139070index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
00194613018825MSI Precision Specialty InstrumentsMed Saver, Inc.GDX2025-08-01
00642356001425Mastel Precision Surgical Instruments, Inc.Mastel Precision Surgical Instruments, Inc.GDX2025-07-08
00642356001432Mastel Precision Surgical Instruments, Inc.Mastel Precision Surgical Instruments, Inc.GDX2025-07-08
00642356001449Mastel Precision Surgical Instruments, Inc.Mastel Precision Surgical Instruments, Inc.GDX2025-07-08
00810111224482Scalpel Treace Medical Concepts, Inc.GDX2025-05-06
00810111224543Scalpel Treace Medical Concepts, Inc.GDX2025-03-25
36945630135805BardSterilance Medical (Suzhou) Inc.GDX2025-03-21
06945630114083BardSterilance Medical (Suzhou) Inc.GDX2025-02-28
05063043035045Swann Morton Ltd.SWANN-MORTON LIMITEDGDX2024-12-27
05063043036042Swann Morton Ltd.SWANN-MORTON LIMITEDGDX2024-12-27
20197344025197MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
20197344025203MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
20197344025210MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
28902895129216KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129223KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129230KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129247KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129285KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129377KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895148095KIATOADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895148101KIATOADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09