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Synergetics

FDA UDI

Class II (US FDA UDI)

by Synergetics Usa, Inc.

Identity

Trade Name
Synergetics FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Device Name
"The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8", 1mm Tip, Insulated, Non-Stick FDA UDI
Model / Reference
DSYN-LB80-10I FDA UDI
Description
"The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8", 1mm Tip, Insulated, Non-Stick FDA UDI

Identifiers

Catalog Number
DSYN-LB80-10I FDA UDI
Primary DI / UDI-DI
20841305110797 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

Synergetics by Synergetics Usa, 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

Manufacturer
Synergetics Usa, Inc.

Sources (1)

  • FDA UDI 4fb4f511-c97a-4d6e-a719-63919e8c6983 35 fields · synced Jun 8, 2026