FDA.report

Swann Morton Ltd.

Primary DI
05063043005123
Brand
Swann Morton Ltd.
Company
SWANN-MORTON LIMITED
Model
No. 25 STERILE DISPOSABLE SCALPELS
Catalog number
0512
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
2022-05-02
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

Related Records

Contact Domains

Product Codes

CodeName
GDXScalpel, One-Piece

Product Code Classifications

CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05033955005122PrimaryGS10
05063043005123Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05033955005122050339550051225033955005122
05063043005123050630430051235063043005123

GMDN Terms

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

Contacts

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 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

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