AccessGUDID - DEVICE: NA (05415067042712)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 405524
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 405524
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05415067042712
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use
Previous DI: 05414734053730

Device Description: Vessel Dilator

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?
38128	Vascular dilator, single-use	A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. 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 [?]
K894330	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
Catheter Gauge: 11.0000 French
Length: 19.0000 Centimeter

Device Record Status

Public Device Record Key: 50b9922c-3b24-4808-9994-e314985615f3
Public Version Date: February 24, 2022
Public Version Number: 1
DI Record Publish Date: February 16, 2022