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
05051471220195De Soutter Medical21630216302026-03-24
05051471220812De Soutter MedicalS83-8069S83-80692026-03-02
05051471220836De Soutter MedicalS83-8169S83-81692026-03-02
05051471220263De Soutter MedicalS89-1482S89-14822026-01-29
05051471219625De Soutter MedicalS83-9499S83-94992026-01-05
05051471215283De Soutter Medical21530215302025-12-04
05051471219038De Soutter MedicalS83-9399S83-93992025-12-04
05051471219175De Soutter MedicalS56-9655S56-96552025-12-04
05051471219199De Soutter MedicalS89-9655S89-96552025-12-04
05051471214453De Soutter Medical21440214402025-09-17
05051471214460De Soutter Medical21450214502025-09-17
05051471214477De Soutter Medical21460214602025-09-17
05051471214484De Soutter Medical21470214702025-09-17
05051471214491De Soutter Medical21480214802025-09-17
05051471214507De Soutter Medical21490214902025-09-17
15051471214788De Soutter MedicalT20-110T20-1102025-09-12
15051471214795De Soutter MedicalT20-173T20-1732025-09-12
15051471217123De Soutter MedicalT20-171T20-1712025-09-12
15051471217130De Soutter MedicalT20-172T20-1722025-09-12
05051471217140De Soutter Medical21520215202025-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06975808863055MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863062MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863079MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863086MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863093MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863109MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863116MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
08717903490501D100 dermatome setHumeca B.V.GFD2025-08-19
08717903490570Humeca D100 Dermatome bladeHumeca B.V.GFD2025-08-19
00860013994006TissueMillTISSUEMILL TECHNOLOGIES LLCGFD2025-05-29
06975808860412MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-05-24
08717903492352Micrograft gauze + cork plate, 1:3, 5-packHumeca B.V.GFD2025-05-20
08717903495421Humeca D42 Dermatome bladeHumeca B.V.GFD2025-05-20
08717903495414Humeca blade for Padgett® model B, C and S dermatomeHumeca B.V.GFD2025-05-20
08717903495407Humeca blade for Aesculap®/Acculan® dermatomeHumeca B.V.GFD2025-05-20
08717903495445Humeca blade for Zimmer® 8801-8821 dermatomeHumeca B.V.GFD2025-05-20
08717903490402D42 dermatome setHumeca B.V.GFD2025-05-20