Identity
- Trade Name
- EnSeal EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- Enseal Temperature Controlled Tissue Sealing Technology Disposable Tissue Sealing Device Taptronic Trigger Activated Power 5mm Jaw Style FDA UDI
- Model / Reference
- NSEAL535RH EUDAMEDFDA UDI
- Description
- Enseal Temperature Controlled Tissue Sealing Technology Disposable Tissue Sealing Device Taptronic Trigger Activated Power 5mm Jaw Style FDA UDI
Identifiers
- Catalog Number
- NSEAL535RH FDA UDI
- Primary DI / UDI-DI
- D-USMF000013107000009MD EUDAMED10705036000044 FDA UDI
- Basic UDI-DI
- B-USMF000013107000009MD EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010201,K0201010202 EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
EnSeal by Ethicon Endo-Surgery, LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000013107000009MD | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED 1287a73a-23ba-4ec3-8d92-08c2ba59c99b 61 fields · synced Jul 16, 2026
- FDA UDI dfa04039-fa1d-4a9d-8d85-7c0bb589c399 36 fields · synced May 30, 2026