AccessGUDID - DEVICE: Prelude PRO™ (10884450331153)

GUDID

Device Identifier (DI) Information

Brand Name: Prelude PRO™
Version or Model: 10884450331153
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRO-7F-11-038MT/C
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 10884450331153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 184763290 *Terms of Use

Device Description: No description.

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):	No
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?
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 [?]
Premarket Submission Number Not Available/Not Released

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: Sheath Length (cm)-11 cm (4.3")
Device Size Text, specify: Sheath French Size (F)-7F
Device Size Text, specify: Guide Wire Diameter-0.038" (0.97 mm)

Device Record Status

Public Device Record Key: 68db019b-8b47-416e-8afe-97ea99d57fce
Public Version Date: October 11, 2021
Public Version Number: 5
DI Record Publish Date: January 18, 2018