DEVICE: MITRACLIP (08717648230967)

Device Identifier (DI) Information

MITRACLIP
CDS0701-NTW
In Commercial Distribution
CDS0701-NTW
ABBOTT VASCULAR INC.
08717648230967
GS1

1
964569052 *Terms of Use
MitraClip G4 Clip Delivery System NTW
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Heart valve clip An implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous clip delivery system (CDS) guided by echocardiographic and fluoroscopic imaging. It is typically made of implant grade metal alloys with a polyester fabric cover. Disposable devices associated with implantation (e.g., CDS and accessories) may be included.
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FDA Product Code

[?]
Product Code Product Code Name
NKM Mitral valve repair devices
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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: Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

0b5a1c2c-e695-4fea-8a78-67c9c701e025
February 05, 2021
2
November 11, 2019
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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)227-9902
AV.CUSTOMERCARE@AV.ABBOTT.COM
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