FDA.reportPublic FDA data

Swann Morton Ltd.

Primary DI
05063043066117
Brand
Swann Morton Ltd.
Company
SWANN-MORTON LIMITED
Model
No. 24 STERILE DISPOSABLE SCALPELS WITH GUARD
Catalog number
6611
Device 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.
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
true
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
05033955066116PrimaryGS10
05063043066117Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033955066116050339550661165033955066116
05063043066117050630430661175063043066117

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

Contacts#

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

Regulatory Flags#

DUNS number
212397483
Device count
10
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05033955001230Swann Morton Ltd.No. 18 NON STERILE BLADES01232022-05-02
05033955001094Swann Morton Ltd.No. 22A NON STERILE BLADES01092022-05-02
05033955001834Swann Morton Ltd.SABRE No. E11 NON STERILE BLADES01832022-05-02
05033955030032Swann Morton Ltd. No. 11 NON STERILE SINGLE PEEL PACK30032022-05-13
05033955030056Swann Morton Ltd.No. 15 NON STERILE SINGLE PEEL PACK30052022-05-13
05033955030070Swann Morton Ltd.No. 21 NON STERILE SINGLE PEEL PACK30072022-05-13
05033955030087Swann Morton Ltd.No. 22 NON STERILE SINGLE PEEL PACK30082022-05-13
05033955030919Swann Morton Ltd.No. 11P NON STERILE SINGLE PEEL PACK30912022-05-13
05033955001209Swann Morton Ltd.No. 15A NON STERILE BLADES01202022-05-02
05033955001223Swann Morton Ltd.No. 16 NON STERILE BLADES01222022-05-02
05033955001247Swann Morton Ltd.No. 19 NON STERILE BLADES01242022-05-02
05033955001117Swann Morton Ltd.No. 24 NON STERILE BLADES01112022-05-02
05033955030018Swann Morton Ltd. No. 10 NON STERILE SINGLE PEEL PACK30012022-05-13
05033955023263Swann-Morton LimitedSTITCH CUTTER BULK NON STERILE DISPOSABLE SCALPELS23262025-08-25
05063043023264Swann-Morton LimitedSTITCH CUTTER BULK NON STERILE DISPOSABLE SCALPELS23262025-08-25
05033955001018Swann Morton Ltd. No. 10 NON STERILE BLADES01012022-05-02
05033955001032Swann Morton Ltd. No. 11 NON STERILE BLADES01032022-05-02
05033955001056Swann Morton Ltd.No. 15 NON STERILE BLADES01052022-05-02
05033955001100Swann Morton Ltd.No. 23 NON STERILE BLADES01102022-05-02
05033955001124Swann Morton Ltd.No. 25 NON STERILE BLADES01122022-05-02

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 Surgical Inc.GDX2025-07-08
00642356001432Mastel Precision Surgical Instruments, Inc.Mastel Surgical Inc.GDX2025-07-08
00642356001449Mastel Precision Surgical Instruments, Inc.Mastel Surgical 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