FDA.reportPublic FDA data

D100 dermatome instrument organizer

Primary DI
08717903490525
Brand
D100 dermatome instrument organizer
Company
Humeca B.V.
Model
4.D100IO
Catalog number
4.D100IO
Published
2025-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717903490525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717903490525087179034905258717903490525

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
489831498
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
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
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
08717903490365D80 dermatome set4.D80STS4.D80STS2025-05-20

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