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Enseal

FDA UDI

Class II (US FDA UDI)

by Ethicon Endo-Surgery, Inc.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI a6f5d75d-a2e3-447d-bbe6-76c9e83dfab0 36 fields · synced Jun 8, 2026