← Back to catalogue

Bipol.pen 25g Lemo Blunt 12bx

FDA UDI

Class II (US FDA UDI)

by Bausch & Lomb, Inc.

Identity

Trade Name
BIPOL.PEN 25G LEMO BLUNT 12BX 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
E7927 FDA UDI
Description
Single Use Medical Device for Ophthalmic Surgery FDA UDI

Identifiers

Catalog Number
E7927 FDA UDI
Primary DI / UDI-DI
04058935000561 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 25g Lemo Blunt 12bx 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA UDI 8aa992b5-5d15-4852-9936-db3676c03425 34 fields · synced May 30, 2026