Identity
- Trade Name
- EDWARDS CERTITUDE INTRODUCER SHEATH SET FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- EDWARDS CERTITUDE INTRODUCER SHEATH SET FDA UDI
- Model / Reference
- 9600IS18 FDA UDI
- Description
- EDWARDS CERTITUDE INTRODUCER SHEATH SET FDA UDI
Identifiers
- Catalog Number
- 9600IS18A FDA UDI
- Primary DI / UDI-DI
- 00690103194173 FDA UDI
- PMA Number
- P140031 FDA UDI
- FDA Product Code
- NPU FDA UDINPT FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Vascular catheter introduction set, nonimplantableAortic transcatheter heart valve bioprosthesis, stent-like frameworkMitral transcatheter heart valve bioprosthesis
Edwards Certitude Introducer Sheath Set by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mitral transcatheter heart valve bioprosthesis.
- Tendyne™ — ST. JUDE MEDICAL, INC. · Class III
- Tendyne™ — ST. JUDE MEDICAL, INC. · Class III
- Tendyne™ — ST. JUDE MEDICAL, INC. · Class III
- Tendyne™ — ST. JUDE MEDICAL, INC. · Class III
- Tendyne™ — ST. JUDE MEDICAL, INC. · Class III
- Tendyne™ — ST. JUDE MEDICAL, INC. · Class III
- Tendyne™ — ST. JUDE MEDICAL, INC. · Class III
- Tendyne™ — ST. JUDE MEDICAL, INC. · Class III
Cleared under the same submission
P140031 also covers:
- Axela Sheath — Edwards Lifesciences LLC
- COMMANDER — Edwards Lifesciences LLC
- EDWARDS CERTITUDE DELIVERY SYSTEM — Edwards Lifesciences LLC
- EDWARDS CERTITUDE DELIVERY SYSTEM — Edwards Lifesciences LLC
- EDWARDS CERTITUDE DELIVERY SYSTEM — Edwards Lifesciences LLC
- EDWARDS CERTITUDE DELIVERY SYSTEM — Edwards Lifesciences LLC
- EDWARDS CERTITUDE INTRODUCER SHEATH SET — Edwards Lifesciences LLC
- EDWARDS COMMANDER DELIVERY SYSTEM — Edwards Lifesciences LLC
- EDWARDS COMMANDER DELIVERY SYSTEM — Edwards Lifesciences LLC
- EDWARDS CRIMPER — Edwards Lifesciences LLC
- EDWARDS CRIMPER — Edwards Lifesciences LLC
- Edwards Certitude Delivery System — Edwards Lifesciences LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 54dab4cc-abdd-4661-be8b-efdeeff3db35 38 fields · synced Jun 8, 2026