DEVICE: EDWARDS CRIMPER (00690103198331)
Device Identifier (DI) Information
EDWARDS CRIMPER
9600CR
In Commercial Distribution
9600CRA
Edwards Lifesciences LLC
9600CR
In Commercial Distribution
9600CRA
Edwards Lifesciences LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
16463 | Basic crimper |
A hand-held manual device designed to compress (pinch) a non-patient-contact sealing device (e.g., a clip or crimping ring of metal applied apart from the body) to reduce its size (diameter) and create a tight seal on objects being clamped or held together. This is performed by the application of force on the grip of the crimper's handles by the operator. This is a reusable device.
|
Active | false |
58865 | Vascular catheter introduction set, nonimplantable |
A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
|
Active | false |
60246 | Mitral transcatheter heart valve bioprosthesis |
An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant mitral heart valve, or previously-implanted mitral heart valve prosthesis, and which is implanted with a catheter via percutaneous access (e.g., transfemoral, transapical) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to a metal framework (which may be covered with a synthetic polymer material) that is expandable in situ; it may also include a synthetic polymer subannular valve anchoring component. Devices to assist implantation (e.g., catheter, introducer) are typically included.
|
Active | true |
60245 | Aortic transcatheter heart valve bioprosthesis, stent-like framework |
An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NPT | Aortic valve, prosthesis, percutaneously delivered |
NPU | Prosthesis, Mitral Valve, Percutaneously Delivered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P140031 | 035 |
P140031 | 074 |
P140031 | 088 |
P140031 | 107 |
P140031 | 182 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: NOT APPLICABLE |
Device Record Status
892b5a37-1fac-4f4b-b751-bbf02b62e040
May 02, 2025
11
December 11, 2017
May 02, 2025
11
December 11, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)822-9637
tech_support@edwards.com
tech_support@edwards.com