DEVICE: EDWARDS CRIMPER (00690103192063)

Device Identifier (DI) Information

EDWARDS CRIMPER
9350CR
In Commercial Distribution
9350CRA
Edwards Lifesciences LLC
00690103192063
GS1

1
134139174 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
NPT Aortic valve, prosthesis, percutaneously delivered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P130009 000
P130009 034
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

344bf84f-3bc9-440f-bff1-a88ea94f9a4a
July 06, 2018
3
August 30, 2014
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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)822-9837
tech_support@edwards.com
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