AccessGUDID - DEVICE: ASCENDRA 3 INTRODUCER SHEATH SET (00690103191912)

GUDID

Device Identifier (DI) Information

Brand Name: ASCENDRA 3 INTRODUCER SHEATH SET
Version or Model: 9120ISA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9120ISA
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103191912
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: No description.

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):
Over the Counter (OTC):
Kit:
Combination Product:
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
10678	Catheter introducer	A sterile tubular plastic sheath designed to be percutaneously placed into a natural body space (e.g., vein, artery, ventricle, peritoneal cavity), or an artificial passageway (e.g., created by means of a catheter tunneller), and through which a catheter is subsequently inserted (by pushing) for placement. It typically has a handle (e.g., T-shaped wing grips) at the proximal end, and may have radiopaque graduated markings at the working end to make it visible on x-ray. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NPT	Aortic valve, prosthesis, percutaneously delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: NOMINAL BALLOON DIAMETER

Device Record Status

Public Device Record Key: c2eb279c-a0bd-499a-9f6f-e4b70d484334
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 30, 2014