Vitrectomy Infusion Sleeve - Non-Sterile

Basic Information

• Brand Name: Vitrectomy Infusion Sleeve - Non-Sterile
• Primary DI: 00632307000386
• Version / Model: PD505.05
• Company Name: PEREGRINE SURGICAL, LTD.
• Labeler DUNS: 622467348
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-06
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 14f6a448-1433-43d3-8dd4-bf5e5890f4cd

Device Description

Vitrectomy Infusion Sleeve - Non-Sterile

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMX	CANNULA, OPHTHALMIC	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16209	Ophthalmic tissue forceps, reusable	A hand-held ophthalmic surgical instrument designed to grasp, manipulate, compress, pull, or join eye and/or surrounding tissues during a surgical intervention. It is typically: 1) a one-piece instrument with a tweezers-like design having two conjoined blades with serrated tips at the working end; or 2) an instrument tip, with grasping blades at the distal end, that is inserted into a dedicated handle through which the blades are operated. It is typically made of high-grade stainless steel and plastic materials, and is available in various sizes. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10632307000383	GS1	Bag	10	In Commercial Distribution
Primary	00632307000386	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Needle Gauge	20	Gauge
Device Size Text, specify			20 Gauge Needle