AccessGUDID - DEVICE: Vessel Dilator (00886333216208)

GUDID

Device Identifier (DI) Information

Brand Name: Vessel Dilator
Version or Model: A392306
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A392306
Company Name: ARGON MEDICAL DEVICES, INC.

Primary DI Number: 00886333216208
Issuing Agency: GS1
Commercial Distribution End Date: December 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 140727624 *Terms of Use

Device Description: Vessel Dilator with Feathered Tip 7 French

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?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRE	Dilator, Vessel, For Percutaneous Catheterization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K780126	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 7 French

Device Record Status

Public Device Record Key: f4187b43-0e55-4096-8154-64b257f23d5a
Public Version Date: December 10, 2024
Public Version Number: 6
DI Record Publish Date: September 20, 2016