Synergetics

Basic Information

• Brand Name: Synergetics
• Primary DI: 10841305111100
• Version / Model: BL5627S
• Catalog Number: BL5627S
• Company Name: SYNERGETICS USA, INC.
• Labeler DUNS: 021056726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-30
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 588aea93-bbc2-4c85-a6e9-2063f1a7108b

Device Description

27ga BiBlade Stellaris PC 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
47424	Vitrectomy system handpiece tip	A sterile, micro-cutting device that is attached to a vitrectomy system handpiece for insertion into the eye, in order to remove (nibble away) the vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The handpiece converts an energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action applied by this knife-like device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20841305111114	GS1	Box	6	In Commercial Distribution
Primary	10841305111100	GS1

Storage Conditions

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