DEVICE: EDWARDS CRIMPER (00690103193978)

Device Identifier (DI) Information

EDWARDS CRIMPER
9600CR
In Commercial Distribution
9600CRA
Edwards Lifesciences LLC
00690103193978
GS1

1
134139174 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
No
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
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FDA Product Code

[?]
Product Code Product Code Name
NPU Prosthesis, Mitral Valve, Percutaneously Delivered
NPT Aortic valve, prosthesis, percutaneously delivered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P140031 000
P140031 020
P140031 028
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: NOT APPLICABLE
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Device Record Status

fd9db834-5d97-498a-9334-016a710dfdcc
July 06, 2018
3
July 05, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)822-9637
tech_support@edwards.com
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