Identity
- Trade Name
- D100 dermatome set FDA UDI
- Generic Name
- Dermatome handpiece, electrically-powered FDA UDI
- Model / Reference
- 4.D100STS FDA UDI
Identifiers
- Catalog Number
- 4.D100STS FDA UDI
- Primary DI / UDI-DI
- 08717903490501 FDA UDI
- FDA Product Code
- GFD FDA UDI
- GMDN Term
- Dermatome handpiece, electrically-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dermatome handpiece, electrically-powered
D100 dermatome set by Humeca B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Humeca B.V.
Sources (1)
- FDA UDI bde4e94e-42c2-49d8-8358-453eae70cfba 34 fields · synced Jun 8, 2026