FDA UDI
In Commercial Distribution
🇺🇸 United States
Protege RX Tapered
DI: 00821684038697
·
Model: SECX-8-6-30-135
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Protege RX Tapered
- Primary DI
- 00821684038697
- Version / Model
- SECX-8-6-30-135
- Company Name
- Covidien LP
- Labeler DUNS
- 968903703
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-22
- Public Version
- 11
- Public Version Date
- 2023-10-12
- Public Version Status
- Update
- Public Device Record Key
- c7c973cd-af8f-42b7-b19a-27e6c8afc1c8
Device Description
Carotid Stent System
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 |
|---|---|---|---|---|
| NIM | STENT, CAROTID | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45851 | Bare-metal carotid artery stent | A non-bioabsorbable tubular device dedicated to implantation in a carotid artery to maintain arterial patency and improve luminal diameter in patients with atherosclerotic disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. 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 | 00821684038697 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P060001 | 019 |
| P060001 | 033 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 30 | Millimeter | |
| Catheter Gauge | 6 | French | |
| Device Size Text, specify | Working Length,135,Centimeter;Compatible Guidewire,.014,Inch;Lumen Diameter,6.5 to 7.5,Millimeter; |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry