FDA UDI
In Commercial Distribution
🇺🇸 United States
XIENCE Skypoint™
DI: 08717648231285
·
Model: 1804300-48
·
ABBOTT VASCULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XIENCE Skypoint™
- Primary DI
- 08717648231285
- Version / Model
- 1804300-48
- Catalog Number
- 1804300-48
- Company Name
- ABBOTT VASCULAR INC.
- Labeler DUNS
- 964569052
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-15
- Public Version
- 1
- Public Version Date
- 2023-12-25
- Public Version Status
- New
- Public Device Record Key
- 35ceedcc-0949-4353-8499-f0d6830de31e
Device Description
XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 3.00 mm x 48 mm / Rapid-Exchange
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NIQ | Coronary drug-eluting stent | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717648231285 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Length | 48.0000 | Millimeter | |
| Stent Diameter | 3.0000 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 25 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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).