FDA.reportPublic FDA data

D42 dermatome set

Primary DI
08717903490358
Brand
D42 dermatome set
Company
Humeca B.V.
Model
4.D42STS
Catalog number
4.D42STS
Published
2025-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08717903490402Direct MarkingGS10
08717903490358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717903490402087179034904028717903490402
08717903490358087179034903588717903490358

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 Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
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
08717903490365D80 dermatome set4.D80STS4.D80STS2025-05-20

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09348811000262INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
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09348811000316INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
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06975808860160MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
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