Synergetics

Basic Information

• Brand Name: Synergetics
• Primary DI: 20841305109715
• Version / Model: 70027SP
• Catalog Number: 70027SP
• Company Name: SYNERGETICS USA, INC.
• Labeler DUNS: 021056726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-07-22
• Public Version: 5
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: 67f6588b-d851-49fe-97fd-b3a976e264a8

Device Description

27ga VersaVIT 2.0™ Procedure Pack with PHOTON™ Mid-Field Illuminator

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
Primary	20841305109715	GS1
Unit of Use	10841305109701	GS1

Storage Conditions

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