FDA.reportPublic FDA data

Swann Morton Ltd.

Primary DI
05033955035266
Brand
Swann Morton Ltd.
Company
SWANN-MORTON LIMITED
Model
STITCH CUTTER NON STERILE DISPOSABLE SCALPEL WITH
Catalog number
3526
Device description
A 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
2024-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZTCutter, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05033955035266PrimaryGS10
05063043035267Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033955035266050339550352665033955035266
05063043035267050630430352675063043035267

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
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
212397483
Device count
500
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

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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