AccessGUDID - DEVICE: CP Stent™ (04046964899393)

GUDID

Device Identifier (DI) Information

Brand Name: CP Stent™
Version or Model: 614359
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 614359
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964899393
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: CMCP010 Mounted Covered CP Stent 2.8 18

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
General aorta endovascular stent-graft	A sterile non-bioabsorbable tubular device intended to be implanted in a non-specific region of 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 a mesh structure made of metal (e.g., platinum, iridium) that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft). It is typically expanded in situ (e.g., balloon-expandable) and disposable devices associated with implantation may be included.

GMDN Preferred Term Name

GMDN Definition

General aorta endovascular stent-graft

A sterile non-bioabsorbable tubular device intended to be implanted in a non-specific region of 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 a mesh structure made of metal (e.g., platinum, iridium) that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft). It is typically expanded in situ (e.g., balloon-expandable) and disposable devices associated with implantation may be included.

FDA Product Code

[?]

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

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter (mm) : 18.000 MM
Device Size Text, specify: Length : 28.000 MM

Device Record Status

Public Device Record Key: dc555765-068f-468c-834e-f7c12bb4f74f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 19, 2016