AccessGUDID - DEVICE: XIENCE Skypoint™ (08717648233203)

GUDID

Device Identifier (DI) Information

Brand Name: XIENCE Skypoint™
Version or Model: 1804275-38
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1804275-38
Company Name: ABBOTT VASCULAR INC.

Primary DI Number: 08717648233203
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 964569052 *Terms of Use

Device Description: XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 2.75 mm x 38 mm / Rapid-Exchange

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:	Yes
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?
56284	Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated	A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NIQ	Coronary drug-eluting stent

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
Storage Environment Temperature: exactly 25 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Store in a dry, dark, cool place. Protect from light. Do not remove from carton until ready for use. Store at 25°C (77°F); excursions permitted between 15-30°C(59-86°F).

Clinically Relevant Size

[?]

Size Type Text
Stent Diameter: 2.75 Millimeter
Stent Length: 38 Millimeter

Device Record Status

Public Device Record Key: 27b70657-a238-4af6-ae6f-ddb35a5bb34a
Public Version Date: November 08, 2022
Public Version Number: 4
DI Record Publish Date: May 27, 2021