AccessGUDID - DEVICE: Gator® clipseal plug (M20682800)

GUDID

Device Identifier (DI) Information

Brand Name: Gator® clipseal plug
Version or Model: 8280
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20682800
Issuing Agency: HIBCC
Commercial Distribution End Date: February 28, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8140190c-55a4-45c4-80d3-b51d2a3056c1
Public Version Date: April 16, 2018
Public Version Number: 3
DI Record Publish Date: September 05, 2016