MACROVAC®

Basic Information

• Brand Name: MACROVAC®
• Primary DI: 00650551027003
• Version / Model: 3201-05P-03-PF
• Catalog Number: 3201-05P-03-PF
• Company Name: PMT CORPORATION
• Labeler DUNS: 039576871
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 4
• Public Version Date: 2019-08-21
• Public Version Status: Update
• Public Device Record Key: 33081f92-0350-4abe-8482-b4f5ee8def9b
• Distribution End Date: 2017-11-30

Device Description

PORTED TIP, POLISH FINISH

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZX	Instrument, Microsurgical	Neurology	882.4525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57822	Surgical irrigation/aspiration handpiece, reusable	A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00650551027003	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	5	French
Length	3	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 58 – 78 Degrees Fahrenheit