FDA UDI
In Commercial Distribution
🇺🇸 United States
PALMAZ Balloon Expandable Stent
DI: 10705032076197
·
Model: P204
·
CORDIS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PALMAZ Balloon Expandable Stent
- Primary DI
- 10705032076197
- Version / Model
- P204
- Catalog Number
- P204
- Company Name
- CORDIS CORPORATION
- Labeler DUNS
- 806136177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-05-07
- Public Version
- 7
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- f4b8df27-5a39-4d06-9292-fd1fe68a7e67
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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 |
|---|---|---|---|---|
| MAF | STENT, CORONARY | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47932 | Peripheral artery stent, bare-metal | A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705032057261 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 10705032076197 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P890017 | 015 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damanged
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight