FDA.reportPublic FDA data

Humeca D100 Dermatome blade

Primary DI
08717903490570
Brand
Humeca D100 Dermatome blade
Company
Humeca B.V.
Model
5.D100BL/1
Catalog number
5.D100BL/1
Published
2025-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
08717903490570PackageGS110In Commercial Distribution
08717903490563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717903490570087179034905708717903490570
08717903490563087179034905638717903490563

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
489831498
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
false
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
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
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
08717903490365D80 dermatome set4.D80STS4.D80STS2025-05-20

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