AccessGUDID - DEVICE: EDWARDS CERTITUDE DELIVERY SYSTEM (00690103194135)

GUDID

Device Identifier (DI) Information

Brand Name: EDWARDS CERTITUDE DELIVERY SYSTEM
Version or Model: 9600SDS20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9600SDS20A
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103194135
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: EDWARDS CERTITUDE DELIVERY SYSTEM

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?
60245	Aortic transcatheter heart valve bioprosthesis, stent-like framework	An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPU	Prosthesis, Mitral Valve, Percutaneously Delivered
NPT	Aortic valve, prosthesis, percutaneously delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P140031	024
P140031	028
P140031	107
P140031	112

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
Special Storage Condition, Specify: COOL, DRY PLACE.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: NOMINAL DEPLOYED BALLOON DIAMETER 20 MILLIMETER

Device Record Status

Public Device Record Key: fcae6b25-f55e-459c-ba6f-4e81c613e440
Public Version Date: July 04, 2022
Public Version Number: 7
DI Record Publish Date: January 09, 2017