FDA.reportPublic FDA data

De Soutter Medical

Primary DI
15051471038308
Brand
De Soutter Medical
Company
DE SOUTTER MEDICAL LIMITED
Model
S11-102
Catalog number
S11-102
Device description
DERMATOME BLADE - SIMPLEX
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GFDDermatome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFDDermatomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15051471038308PackageGS15In Commercial Distribution
05051471038301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505147103830815051471038308
05051471038301050514710383015051471038301

GMDN Terms#

Term, Definition table
TermDefinition
Dermatome blade, single-useA surgical cutting device that is designed to be mounted onto a dermatome handle/handpiece (not included) and used to provide the cutting edge for the harvesting of skin grafts or excision of small skin lesions. It is available in various sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458064144
Device count
1
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
05051471186002De Soutter Medical20250202502022-11-28
05051471186019De Soutter Medical20270202702022-11-28
05051471006942De Soutter Medical701070102022-11-28
05051471022232De Soutter Medical89522895222022-11-28
05051471040922De Soutter Medical865086502022-11-28
05051471044852De Soutter Medical882088202022-11-28
05051471005020De Soutter Medical617061702022-11-25
05051471006867De Soutter Medical75942759422022-11-25
05051471022386De Soutter Medical89932899322022-11-25
05051471027152De Soutter Medical755075502022-11-25
05051471121270De Soutter MedicalS56-703S56-7032023-06-16
05051471128217De Soutter MedicalS56-705S56-7052023-06-16
05051471118416De Soutter MedicalS56-702S56-7022023-06-16
05051471142084De Soutter Medical17670176702022-11-28
05051471225565De Soutter Medical21810218102026-08-03
05051471225541De Soutter Medical21800218002026-08-01
05051471225985De Soutter MedicalR52-220R52-2202026-08-01
05051471223844De Soutter Medical21710217102026-07-21
05051471223851De Soutter Medical21720217202026-07-21
05051471223868De Soutter Medical21730217302026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975808860429MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-21
06975808860436MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-21
06975808860443MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-21
16975808860112MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
16975808860174MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
16975808860181MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
26975808860119MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
26975808860171MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
26975808860188MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
05055445901165SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901172SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901189SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901196SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901202SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901219SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901226SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05056111338759SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
09348811000262INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811000293INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811000316INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811172082INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
06975808860160MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808860177MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808860184MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808860191MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863000MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863017MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863024MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863031MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863048MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28