Consulting Wallah › Device Explorer › Other devices › Dermatome handpiece, electrically-powered
Device Explorer · FDA GUDID · GMDN 11179

Dermatome handpiece, electrically-powered

An 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.

US‑registered devices75in commercial distribution
Companies11labelers on GUDID
Single‑use7%of device records
Sterile3%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Integra Lifesciences Corporation3952%
Zimmer Orthopaedic Surgical Products, Inc.79%
Nouvag Ag68%
Kci Usa, Inc.57%
De Soutter Medical Limited45%
Tara Medical Devices, Llc45%
Karl Storz Gmbh & Co. Kg34%
Humeca B.V.34%

Top labelers

CompanyDevicesShare
Integra Lifesciences Corporation3952%
Zimmer Orthopaedic Surgical Products, Inc.79%
Nouvag Ag68%
Kci Usa, Inc.57%
De Soutter Medical Limited45%
Tara Medical Devices, Llc45%
Karl Storz Gmbh & Co. Kg34%
Humeca B.V.34%
Cochlear Bone Anchored Solutions Ab23%
Aesculap Ag11%
Princeton Medical Group, Inc.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

De Soutter Medicaln.a.ACCULAN 3TITissue Bank DermatomeNADermatomeCELLUTOME™PRINCETONIntegra® Padgett® DermatomesIntegra® Padgett®BahaDriver PinD100 dermatome setD80 dermatome setD42 dermatome setEPITECH

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GFDDERMATOME40
GFDDermatome35
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED3
LXBHearing aid, bone conduction2
MDMInstrument, Manual, Surgical, General Use1

GMDN & GCC registration

  • GMDN code 11179 · non‑implantable
  • Single‑use 7% · sterile 3% · Rx‑only 88% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 6

Use these as the dimensions to specify in a tender line.

How many dermatome handpiece, electrically-powered products are registered in the US?

75 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dermatome handpiece, electrically-powered", from 11 companies. The largest labeler is Integra Lifesciences Corporation with 52% of records.

Which FDA product codes apply?

GFD (DERMATOME), GFD (Dermatome), GEY (MOTOR, SURGICAL INSTRUMENT, AC-POWERED), LXB (Hearing aid, bone conduction)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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