AccessGUDID - DEVICE: VersaCross™ Steerable Access Solution (00685447019619)

GUDID

Device Identifier (DI) Information

Brand Name: VersaCross™ Steerable Access Solution
Version or Model: VSTK0103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VSTK0103
Company Name: Baylis Médicale Cie Inc

Primary DI Number: 00685447019619
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 249225954 *Terms of Use

Device Description: Steerable Access Solution

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:	Yes
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?
47247	Cardiac transseptal access set	A collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OFK	Percutaneous atrial catheter kit

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
Device Size Text, specify: 72cm 8.5F VersaCross Steerable Sheath with Medium Curl; 95cm 8.5F VersaCross Transseptal Dilator with Standard Curve D0; 180cm 0.035 in OD J-tip VersaCross RF Wire

Device Record Status

Public Device Record Key: 9839b56a-3b14-4a23-936d-f37e38ae65b2
Public Version Date: March 05, 2025
Public Version Number: 1
DI Record Publish Date: February 25, 2025