Identity
- Trade Name
- Disposable Sheath FDA UDI
- Generic Name
- Electrosurgical system monitor/shield FDA UDI
- Model / Reference
- ES0150A FDA UDI
Identifiers
- Catalog Number
- ES0150A FDA UDI
- Primary DI / UDI-DI
- 10815288010675 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system monitor/shield 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 35 Centimeter FDA UDI
Category: Electrosurgical system monitor/shield
Disposable Sheath by Encision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191612 also covers:
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K912780 also covers:
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- 5mm Endo Cinch Extreme Atraumatic Grasper, Slide Lock Handle, With Rotation — ENCISION, INC.
- AEM® Disposable Curved Scissors — ENCISION, INC.
- AEM® Disposable Curved Scissors — ENCISION, INC.
- AEM® Disposable Curved Scissors — ENCISION, INC.
- AEM® Disposable Curved Scissors — ENCISION, INC.
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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 0e4814d9-d8fd-431d-84b0-5a68d407b387 35 fields · synced May 30, 2026