AccessGUDID - DEVICE: FlexPoint (B378STSN1871DC0)

GUDID

Device Identifier (DI) Information

Brand Name: FlexPoint
Version or Model: STSN-18-71-DC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STSN-18-71-DC
Company Name: INDIAN WELLS MEDICAL, INC.

Primary DI Number: B378STSN1871DC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078634163 *Terms of Use

Device Description: Steerable Transseptal Needle

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?
47248	Cardiac transseptal needle, single-use	A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRC	Trocar

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
Length: 71 Centimeter

Device Record Status

Public Device Record Key: 6206e1b0-dace-4cdc-99b4-30794030f067
Public Version Date: August 20, 2020
Public Version Number: 4
DI Record Publish Date: January 12, 2017