AccessGUDID - DEVICE: iCast Covered Stent System, 9mmX38mmX80cm (00650862489385)

GUDID

Device Identifier (DI) Information

Brand Name: iCast Covered Stent System, 9mmX38mmX80cm
Version or Model: 48938
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 48938
Company Name: Atrium Medical Corporation

Primary DI Number: 00650862489385
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051798999 *Terms of Use

Device Description: iCast Covered Stent System, 9mmX38mmX80cm

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?
43526	Peripheral artery endovascular stent-graft, non-medicated	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain patency and improve luminal diameter, typically in patients with symptomatic peripheral vascular disease or following the recanalization of a total occlusion. It may be intended for implantation in an artery adjacent to the aorta (e.g., iliac, renal), however it is not a dedicated component of an aortoiliac stent-graft assembly; it may additionally be intended for venous implantation. It is a metallic mesh-like structure with a synthetic polymer tube (endovascular graft); it does not include pharmaceuticals.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PRL	Iliac Covered Stent, Arterial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P120003	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 59 and 77 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Stent Diameter: 9 Millimeter
Stent Length: 38 Millimeter
Catheter Length: 80 Centimeter

Device Record Status

Public Device Record Key: 080ed152-e927-418a-a250-5f0b4969c97d
Public Version Date: December 11, 2024
Public Version Number: 3
DI Record Publish Date: June 09, 2023