DEVICE: Zenith Spiral-Z (10827002552279)

Device Identifier (DI) Information

Zenith Spiral-Z
G55227
In Commercial Distribution
ZSLE-11-90-ZT
COOK INCORPORATED
10827002552279
GS1

1
042823948 *Terms of Use
Zenith, Spiral-Z AAA Iliac Leg
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Device Characteristics

MR Conditional
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?
46777 Abdominal aorta endovascular stent-graft
A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is typically made of a metallic outer mesh structure with an inner polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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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: Store in dark, dry, cool place.
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Clinically Relevant Size

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

f07fe712-c84a-4b9f-8e20-39fc36a16d5d
December 12, 2024
5
September 24, 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
Yes
No CLOSE

Customer Contact

[?]
+1(812)330-5494
sharedservices@cookmedical.com
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