FDA UDI
In Commercial Distribution
🇺🇸 United States
Protégé™ GPS™
DI: 00643169729155
·
Model: SERB65-12-40-80
·
EV3, INC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Protégé™ GPS™
- Primary DI
- 00643169729155
- Version / Model
- SERB65-12-40-80
- Company Name
- EV3, INC
- Labeler DUNS
- 117446916
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-01
- Public Version
- 8
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 0de47313-0638-4184-8c68-a34abb95dd4f
Device Description
STENT SERB65-12-40-80 PROTEGE GPS V06
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NIO | STENT, ILIAC | Unknown | 3 | |
| FGE | CATHETER, BILIARY, DIAGNOSTIC | Gastroenterology, Urology | 876.5010 | 2 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00643169729155 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P060001 | 020 |
| P060001 | 029 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 6.0 | French | |
| Length | 40.0 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry