AccessGUDID - DEVICE: RelayPro Thoracic Stent-Graft System (00843576168923)

GUDID

Device Identifier (DI) Information

Brand Name: RelayPro Thoracic Stent-Graft System
Version or Model: 28-N4-32-090-38U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 28-N4-32-090-38U
Company Name: Bolton Medical Inc.

Primary DI Number: 00843576168923
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 847424462 *Terms of Use

Device Description: Endovascular Stent-Graft System

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
48060	Descending thoracic aorta endovascular stent-graft	A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200045	000
P200045	001
P200045	002
P200045	003

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
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 32 Millimeter
Outer Diameter: 38 Millimeter
Length: 106 Millimeter
Catheter Gauge: 22 French

Device Record Status

Public Device Record Key: 10a4583e-0d9a-4eca-86f7-762cfd5c6ec0
Public Version Date: December 11, 2024
Public Version Number: 4
DI Record Publish Date: May 04, 2022