AccessGUDID - DEVICE: Teirstein Edge™ device organizer (M20681500)

GUDID

Device Identifier (DI) Information

Brand Name: Teirstein Edge™ device organizer
Version or Model: 8150
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vascular Solutions, Inc.

Primary DI Number: M20681500
Issuing Agency: HIBCC
Commercial Distribution End Date: February 28, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 008999906 *Terms of Use

Device Description: The Teirstein Edge Device Organizer is intended to stabilize and load guidewires and catheters during percutaneous procedures.

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?
35954	Medical device rail	A device in the form of a narrow bar designed to be fixed on the wall for mounting and organizing medical devices [e.g., in hospital wards, treatment rooms, intensive care units (ICU)]; the equipment to be supported is not included. It may be used in conjunction with clamps and/or poles. It is available in various lengths.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTY	Tape, Measuring, Rulers And Calipers

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 6c5df596-e111-4ab0-87e8-94910e0c202e
Public Version Date: December 11, 2024
Public Version Number: 4
DI Record Publish Date: September 05, 2016