Synergetics

Basic Information

• Brand Name: Synergetics
• Primary DI: 10841305111438
• Version / Model: SE5625
• Catalog Number: SE5625
• Company Name: SYNERGETICS USA, INC.
• Labeler DUNS: 021056726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 78345961-f852-4425-9be1-492c2c4c7257

Device Description

25ga Stellaris Elite Vitrectomy Probe

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: 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
59528	Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict hereditary cerebral haemorrhage with amyloidosis (Dutch type), associated with mutations in the gene encoding the amyloid precursor protein (APP), using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20841305111442	GS1	Box	6	In Commercial Distribution
Primary	10841305111438	GS1

Storage Conditions

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