BIPOL.PEN 25G LEMO BLUNT 12BX

Basic Information

• Brand Name: BIPOL.PEN 25G LEMO BLUNT 12BX
• Primary DI: 04058935000561
• Version / Model: E7927
• Catalog Number: E7927
• Company Name: Bausch & Lomb GmbH
• Labeler DUNS: 342397433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 4
• Public Version Date: 2018-10-29
• Public Version Status: Update
• Public Device Record Key: 8aa992b5-5d15-4852-9936-db3676c03425

Device Description

Single Use Medical Device for Ophthalmic Surgery

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXI	Probe, Radiofrequency Lesion	Neurology	882.4725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56296	Open-surgery electrosurgical handpiece/electrode, bipolar, single-use	A sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04058935000561	GS1
Unit of Use	24058935000565	GS1