Identity
- Trade Name
- Integra® Padgett® Dermatomes FDA UDI
- Generic Name
- Dermatome blade, single-use FDA UDI
- Device Name
- Blade, Dermatome (For Manual Models, Baby Size)(6 languages) FDA UDI
- Model / Reference
- 3539106 FDA UDI
- Description
- Blade, Dermatome (For Manual Models, Baby Size)(6 languages) FDA UDI
Identifiers
- Catalog Number
- 3539106 FDA UDI
- Primary DI / UDI-DI
- 10381780277958 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
Integra® Padgett® Dermatomes by Integra Lifesciences Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatome blade, single-use.
- Blade for Mucotome — Nouvag AG · Class I
- Blade for Dermatome 12mm — Nouvag AG · Class I
- Humeca D100 Dermatome blade — Humeca B.V. · Class I
- TissueMill — TISSUEMILL TECHNOLOGIES LLC · 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
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI aff7f41c-3fd0-400c-b8d3-2ad7fc866ded 35 fields · synced Jun 8, 2026