AccessGUDID - DEVICE: SafeSept® NF Transseptal Guidewire Needle Free (00891492002401)

GUDID

Device Identifier (DI) Information

Brand Name: SafeSept® NF Transseptal Guidewire Needle Free
Version or Model: SSNF
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SSNF
Company Name: Oscor Inc.

Primary DI Number: 00891492002401
Issuing Agency: GS1
Commercial Distribution End Date: December 06, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 101835833 *Terms of Use

Device Description: Transseptal Guidewire Needle Free

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 [?]
K130843	000

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
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 150 Centimeter
Outer Diameter: 0.0315 Inch

Device Record Status

Public Device Record Key: d0dc2e44-128a-41d4-b641-cc8cd91b1c4a
Public Version Date: January 09, 2023
Public Version Number: 5
DI Record Publish Date: November 27, 2017