FDA.reportPublic FDA data

Swann Morton Ltd.

Primary DI
05063043039197
Brand
Swann Morton Ltd.
Company
SWANN-MORTON LIMITED
Model
No. 14 STERILE RETRACTABLE SCALPELS
Catalog number
3919
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
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
05033955039196PrimaryGS10
05063043039197Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033955039196050339550391965033955039196
05063043039197050630430391975063043039197

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
25
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227346Scalpel Treace Medical Concepts, Inc.GDX2026-05-19
00850069257002LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257019LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257026LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257040LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257057LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257064LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257071LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257088LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257095LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257101LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257118LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257033LumohsNANO SURGICAL, INCGDX2026-02-20
16945630141826STERiLANCESterilance Medical (Suzhou) Inc.GDX2026-02-05
00818788021892Epimed International, Inc.EPIMED INTERNATIONAL, INCGDX2025-11-21
16945630137584index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137591index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137607index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137614index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139069index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139076index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
10198459343490MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GDX2025-05-22
16945630114080BardSterilance Medical (Suzhou) Inc.GDX2025-02-28
10197344025190MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025206MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025213MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
08902895129212KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129229KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129236KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129243KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09