ProTack

Basic Information

• Brand Name: ProTack
• Primary DI: 10884521070400
• Version / Model: 174006
• Catalog Number: 174006
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8e723475-ac10-4a4a-82b5-3a282d3df005

Device Description

Fixation Device

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: MR Conditional
• Direct Marking Exempt: No
• 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
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45613	Surgical binding material anchor set	A collection of devices designed to implant a non-bioabsorbable fixation anchor into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials (e.g., mesh, sutures). The set typically consists of non-bioabsorbable fixation anchors, possibly contained within a cartridge, and a mechanical applicator used to hold, position, and insert each anchor into the target tissue; and possibly a drill or punch to create the hole to deliver the anchor. This is a single-patient device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521070407	GS1	CASE	6	In Commercial Distribution
Primary	10884521070400	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090470	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5	Millimeter