Synergetics

Basic Information

• Brand Name: Synergetics
• Primary DI: 10841305106267
• Version / Model: 65035E
• Catalog Number: 65035E
• Company Name: SYNERGETICS USA, INC.
• Labeler DUNS: 021056726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-23
• Public Version: 5
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: 2b898cf0-db3f-47ba-8287-472888efb430

Device Description

25ga Core Essentials™ Vitrectomy Pack, 3ft Cutter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HQE	Instrument, vitreous aspiration and cutting, ac-powered	Ophthalmic	886.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20841305109548	GS1	Box	6	In Commercial Distribution
Primary	10841305106267	GS1

Storage Conditions

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