AccessGUDID - DEVICE: BRK-1™ (05414734205177)

GUDID

Device Identifier (DI) Information

Brand Name: BRK-1™
Version or Model: 407207
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 407207
Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Primary DI Number: 05414734205177
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040960379 *Terms of Use

Device Description: 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
Special Storage Condition, Specify: Keep dry. Keep away from sunlight. Protect from heat and radioactive source

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.3 Millimeter
Length: 98 Centimeter

Device Record Status

Public Device Record Key: 7a050e2e-3bb8-43b0-ae10-b989d9958760
Public Version Date: October 30, 2023
Public Version Number: 5
DI Record Publish Date: November 13, 2015