AccessGUDID - DEVICE: iCAST (00650862854039)

GUDID

Device Identifier (DI) Information

Brand Name: iCAST
Version or Model: 85403
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Atrium Medical Corporation

Primary DI Number: 00650862854039
Issuing Agency: GS1
Commercial Distribution End Date: February 29, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 051798999 *Terms of Use

Device Description: iCAST COVERED STENT, 6MMX59MMX80CM

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):	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?
43630	Polymer-metal tracheal/bronchial stent	A non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lining, or polymeric tubular body with metallic support structures), and may have a straight or branched configuration. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JCT	Prosthesis, tracheal, expandable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050814	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a2e1a964-1ba0-4e6d-90f8-f329d32f139f
Public Version Date: February 29, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2015