Synergetics

Basic Information

• Brand Name: Synergetics
• Primary DI: 10841305105192
• Version / Model: P2-PLAMP
• Catalog Number: P2-PLAMP
• Company Name: SYNERGETICS USA, INC.
• Labeler DUNS: 021056726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-18
• Public Version: 4
• Public Version Date: 2022-12-26
• Public Version Status: Update
• Public Device Record Key: 654427c9-6734-4979-a348-efce8776c162

Device Description

PHOTON™ II Replacement Lamp

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ONE	Powered light based non-laser surgical instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45124	Ophthalmic fibreoptic light instrument, reusable	A hand-held, ophthalmic, surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a light cable, that may, or may not be part of the device, to a light source. It is made of high-grade stainless steel and has a fibreoptic bundle core that conducts the light. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841305105192	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit