FDA.reportPublic FDA data

Swann Morton Ltd.

Primary DI
05033955009052
Brand
Swann Morton Ltd.
Company
SWANN-MORTON LIMITED
Model
No. 5B STAINLESS SURGICAL HANDLE
Catalog number
0905
Device description
Knife/blade handle. A metal surgical instrument e.g. stainless steel or brass, designed to mount a compatible blade used for cutting or dissecting tissue.
Published
2022-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05033955009052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033955009052050339550090525033955009052

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
212397483
Device count
1
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810055255689Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255696Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255702Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255726Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255788Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255801Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255825Surgical DesignSurgical Design, Inc.GDZ2026-06-26
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00810055256105Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256112Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256129Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256136Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256150Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256174Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256181Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256198Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256204Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810189455139Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00190776421847MillenniumAvalign Technologies, Inc.GDZ2026-06-25
00810055257348Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257355Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257362Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257379Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257386Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257850Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00190776421533MillenniumAvalign Technologies, Inc.GDZ2026-05-05
00190776419769MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419776MillenniumAvalign Technologies, Inc.GDZ2026-04-15