Gator® clipseal plug

Basic Information

• Brand Name: Gator® clipseal plug
• Primary DI: M20682800
• Version / Model: 8280
• Company Name: Vascular Solutions, Inc.
• Labeler DUNS: 008999906
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-05
• Public Version: 3
• Public Version Date: 2018-04-16
• Public Version Status: Update
• Public Device Record Key: 8140190c-55a4-45c4-80d3-b51d2a3056c1
• Distribution End Date: 2018-02-28

Device Description

The GATOR is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires.

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: 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
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	870.4290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34099	In-line backflow valve, single-use	A general-purpose device used in medical or laboratory tubing to prevent the backflow of gases or liquids. It will typically have a small ball or a leaf valve that instantly closes should a retrograde pressure (backflow) occur. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M20682800	HIBCC
Package	M20682801	HIBCC	Box	10	Not in Commercial Distribution	2018-02-28

Customer Contacts

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