Identity
- Trade Name
- Enseal FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- Enseal Tissue Sealer G2 Super Jaw curved for use with Generator G11 22cm Shaft length FDA UDI
- Model / Reference
- NSEALX22L FDA UDI
- Description
- Enseal Tissue Sealer G2 Super Jaw curved for use with Generator G11 22cm Shaft length FDA UDI
Identifiers
- Catalog Number
- NSEALX22L FDA UDI
- Primary DI / UDI-DI
- 10705036013808 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use 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
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Enseal by Ethicon Endo-Surgery, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, single-use.
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- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Symmetry Olsen — Olsen Medical · Class II
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 |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (1)
- FDA UDI a6f5d75d-a2e3-447d-bbe6-76c9e83dfab0 36 fields · synced Jun 8, 2026