FDA.reportPublic FDA data

Swann Morton Ltd.

Primary DI
05033955006396
Brand
Swann Morton Ltd.
Company
SWANN-MORTON LIMITED
Model
STAINLESS SWANN MAJOR HANDLE
Catalog number
0639
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
2022-09-22
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
05033955006396PrimaryGS10
05063043006397Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033955006396050339550063965033955006396
05063043006397050630430063975063043006397

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
10
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
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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
00190776419783MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776418410MillenniumAvalign Technologies, Inc.GDZ2026-03-25
09348811000040INKAThe Trustee for KAISER FAMILY TRUSTGDZ2025-11-19
B382SD9045551000Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
B382SD9045551010Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
B382SD9045551020Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
B382SD9045551030Surgical DirectSurgical Direct, Inc.GDZ2025-09-10
16945630137621index AsuritySterilance Medical (Suzhou) Inc.GDZ2025-08-25
16945630137638index AsuritySterilance Medical (Suzhou) Inc.GDZ2025-08-25
38886354702639Anzen Safety ScalpelMEDIPURPOSE PTE. LTD.GDZ2025-02-12
B382SD904320210Surgical DirectSurgical Direct, Inc.GDZ2024-07-11
M944AL019130Wexler Surgical, Inc.WEXLER SURGICAL, INC.GDZ2024-02-12
M944AL019230Wexler Surgical, Inc.WEXLER SURGICAL, INC.GDZ2024-02-12
14026704922991PILLINGTELEFLEX INCORPORATEDGDZ2023-11-07
10620974003318SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003325SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003332SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003349SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003356SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
G25001001030Scalpel Handle No.3N S SURGICAL COMPANYGDZ2023-01-31
G25001002040Scalpel Handle No.4N S SURGICAL COMPANYGDZ2023-01-31