Identity
- Trade Name
- Amalgatome SD 4-inch Lock Ring FDA UDI
- Generic Name
- Dermatome handpiece, pneumatic FDA UDI
- Device Name
- Lock Ring 4" ASD FDA UDI
- Model / Reference
- X100825 FDA UDI
- Description
- Lock Ring 4" ASD FDA UDI
Identifiers
- Catalog Number
- X100825 FDA UDI
- Primary DI / UDI-DI
- 00810006780062 FDA UDI
- FDA Product Code
- GFD FDA UDI
- GMDN Term
- Dermatome handpiece, pneumatic 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4 Inch FDA UDI
Category: Dermatome handpiece, pneumatic
Amalgatome SD 4-inch Lock Ring by Exsurco Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dermatome handpiece, pneumatic.
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- Integra® Padgett® — Integra Lifesciences Corp. · Class I
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- Amalgatome SD System (2" & 4") — EXSURCO MEDICAL, INC. · Class I
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- Amalgatome SD 4-inch Cutting Head — EXSURCO MEDICAL, INC. · 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
- Exsurco Medical, Inc.
Sources (1)
- FDA UDI db0f78d7-1923-4351-897f-ba54150d689d 37 fields · synced May 30, 2026