AccessGUDID - DEVICE: PRECISE (20705032035542)

GUDID

Device Identifier (DI) Information

Brand Name: PRECISE
Version or Model: P09030RXB
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: P09030RXB
Company Name: CORDIS CORPORATION

Primary DI Number: 20705032035542
Issuing Agency: GS1
Commercial Distribution End Date: August 08, 2024
Device Count: 2
Labeler D-U-N-S® Number*: 806136177 *Terms of Use

Device Description: CORDIS PRECISE RX NITINOL

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?
45851	Bare-metal carotid artery stent	A non-bioabsorbable tubular device dedicated to implantation in a carotid artery to maintain arterial patency and improve luminal diameter in patients with atherosclerotic disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIM	STENT, CAROTID

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030047	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: 04d5d646-e063-4f89-bc37-b7862e31fe52
Public Version Date: August 09, 2024
Public Version Number: 8
DI Record Publish Date: September 19, 2017