Identity
- Trade Name
- Blade for Dermatome 100mm FDA UDI
- Generic Name
- Dermatome blade, single-use FDA UDI
- Device Name
- Blade for Dermatome 100mm FDA UDI
- Model / Reference
- 1919 FDA UDI
- Description
- Blade for Dermatome 100mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- ENOU19199 FDA UDI
- FDA Product Code
- GFD FDA UDI
- GMDN Term
- Dermatome blade, single-use 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatome blade, single-use
Blade for Dermatome 100mm by Nouvag AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatome blade, single-use.
- Integra® Padgett® Dermatomes — Integra Lifesciences Corp. · Class I
- Humeca D100 Dermatome blade — Humeca B.V. · Class I
- TissueMill — TISSUEMILL TECHNOLOGIES LLC · Class I
- Integra® Padgett® Dermatomes — Integra Lifesciences Corp. · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Dermatome — Zimmer Orthopaedic Surgical Products · Class I
- Padgett Replacement Dermatome Blades Non-Sterile — ROBBINS INSTRUMENTS · Class I
- Bioseal Inc. — BIOSEAL · Class I
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
- Nouvag AG
Sources (1)
- FDA UDI bb0c0c67-8f8a-49e6-a815-2e2bcc55f9ae 34 fields · synced Jun 1, 2026