Identity
- Trade Name
- AEM® Handle FDA UDI
- Generic Name
- Electrosurgical handpiece, reusable FDA UDI
- Model / Reference
- ES8000 FDA UDI
Identifiers
- Catalog Number
- ES8000 FDA UDI
- Primary DI / UDI-DI
- 10815288010231 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical handpiece, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 35 Centimeter FDA UDI
Category: Electrosurgical handpiece, reusable
AEM® Handle by Encision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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- AEM® Handle — ENCISION, INC.
- AEM® Handle — ENCISION, INC.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Encision, Inc.
Sources (1)
- FDA UDI 4064864e-f443-4828-9000-9107424e0f78 35 fields · synced May 31, 2026