AccessGUDID - DEVICE: CP Stent™ (04046964898969)

GUDID

Device Identifier (DI) Information

Brand Name: CP Stent™
Version or Model: 614315
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 614315
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964898969
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: MCP004 Mounted CP Stent 2.2 12 2.5 8F

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Bare-metal aortic stent	A sterile non-bioabsorbable tubular device intended to be implanted in the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

GMDN Preferred Term Name

GMDN Definition

Bare-metal aortic stent

A sterile non-bioabsorbable tubular device intended to be implanted in the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

FDA Product Code

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Product Code	Product Code Name
PNF	Aortic stent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150028	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

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Storage and Handling
Storage Environment Temperature: between 5 and 45 Degrees Celsius
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Diameter (mm) : 12.000 MM
Device Size Text, specify: Length : 22.000 MM

Device Record Status

Public Device Record Key: f565dae4-b7dc-4071-bf0b-12f1e05d9ba7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 19, 2016