FDA.reportPublic FDA data

D80 dermatome set

Primary DI
08717903490365
Brand
D80 dermatome set
Company
Humeca B.V.
Model
4.D80STS
Catalog number
4.D80STS
Published
2025-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
08717903490419Direct MarkingGS10
08717903490365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717903490419087179034904198717903490419
08717903490365087179034903658717903490365

GMDN Terms#

Term, Definition table
TermDefinition
Dermatome handpiece, electrically-poweredAn electrically-powered, hand-held surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade (not included). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
489831498
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717903490594Humeca MAX Mesher6.M1006.M1002026-03-31
08717903490600Humeca MAX Mesher instrument organizer6.M100IO6.M100IO2026-03-31
08717903490617Humeca MAX Carrier 1:1 6.M100-1.0/16.M100-1.0/12026-03-31
08717903490624Humeca MAX Carrier 1:1.56.M100-1.5/16.M100-1.5/12026-03-31
08717903490631Humeca MAX Carrier 1:26.M100-2.0/16.M100-2.0/12026-03-31
08717903490648Humeca MAX Carrier 1:36.M100-3.0/16.M100-3.0/12026-03-31
08717903490716Humeca MAX Carrier 1:2.56.M100-2.5/16.M100-2.5/12026-03-31
08717903490723Humeca MAX Carrier 1:46.M100-4.0/16.M100-4.0/12026-03-31
08717903490563Humeca D100 Dermatome blade5.D100BL/15.D100BL/12025-08-19
08717903490501D100 dermatome set4.D100STS4.D100STS2025-08-19
08717903490525D100 dermatome instrument organizer4.D100IO4.D100IO2025-08-19
08717903490570Humeca D100 Dermatome blade5.D100BL/15.D100BL/12025-08-19
08717903490020Micrograft gauze + cork plate, 1:3, 5-pack2.3/52.3/52025-05-20
08717903490174Humeca D42 Dermatome blade5.D42BL/15.D42BL/12025-05-20
08717903490181Humeca blade for Padgett® model B, C and S dermatome5.BLPG/15.BLPG/12025-05-20
08717903490198Humeca blade for Aesculap®/Acculan® dermatome5.BL4245/15.BL4245/12025-05-20
08717903490204Humeca blade for Zimmer® 8801-8821 dermatome5.BLZM/15.BLZM/12025-05-20
08717903490228Humeca blade for Silver knife5.BLSIL/15.BLSIL/12025-05-20
08717903490242Humeca blade for Humby long knife (20cm/7.9 in)5.BLHUL/15.BLHUL/12025-05-20
08717903490358D42 dermatome set4.D42STS4.D42STS2025-05-20

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