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Bipol.pen Scleral Lemo 12/Bx

FDA UDI

Class II (US FDA UDI)

by Bausch & Lomb, Inc.

Identity

Trade Name
BIPOL.PEN SCLERAL LEMO 12/BX FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Device Name
Single Use Medical Device for Ophthalmic Surgery FDA UDI
Model / Reference
E7928 FDA UDI
Description
Single Use Medical Device for Ophthalmic Surgery FDA UDI

Identifiers

Catalog Number
E7928 FDA UDI
Primary DI / UDI-DI
04058935000578 FDA UDI
FDA Product Code
GXI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4725 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

Yes

FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Bipol.pen Scleral Lemo 12/Bx by Bausch & Lomb, 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
Bausch & Lomb, Inc.

Sources (1)

  • FDA UDI 8b534dc3-8377-46da-8c2a-2f43c5c1145a 34 fields · synced Jun 1, 2026