Identity
- Trade Name
- Integra® Padgett® FDA UDI
- Generic Name
- Dermatome handpiece, electrically-powered FDA UDI
- Device Name
- Integra® Padgett® Dermatomes Hand piece, SB Model - USA/Canada Only FDA UDI
- Model / Reference
- DP0810 FDA UDI
- Description
- Integra® Padgett® Dermatomes Hand piece, SB Model - USA/Canada Only FDA UDI
Identifiers
- Catalog Number
- DP0810 FDA UDI
- Primary DI / UDI-DI
- 10381780278030 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
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
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
Category: Dermatome handpiece, electrically-powered
Integra® Padgett® by Integra Lifesciences Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatome handpiece, electrically-powered.
- Tissue Bank Dermatome — Zimmer Orthopaedic Surgical Products · Class I
- CELLUTOME™ — KCI USA, INC. · Class I
- Dermatome — Zimmer Orthopaedic Surgical Products · Class I
- Dermatome — Zimmer Orthopaedic Surgical Products · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- Dermatome 100mm — Nouvag AG · Class I
- EPITECH — TARA MEDICAL DEVICES LLC · Class I
- Tissue Bank Dermatome — Zimmer Orthopaedic Surgical Products · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 75d615da-518c-410c-9d9d-19dbc3272beb 35 fields · synced May 31, 2026