DEVICE: Agilis™ (05414734206167)

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Device Identifier (DI) Information

Agilis™
408312
408312
ST. JUDE MEDICAL, INC.
05414734206167
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Vascular catheter introduction kit, steerable, single-use A collection of sterile, invasive devices intended to provide percutaneous vascular access to enable introduction of a cardiac device/catheter (e.g., cardiac ablation catheter, pacing lead); it is not intended for sub-xiphoid access. It includes a steerable catheter-introducer sheath/dilator assembly intended to be introduced within the cardiac anatomy, a guidewire, and sometimes additional access devices (e.g., introducer needle, haemostatic valve); the catheter is not included. The introducer sheath may include electrodes to assist electrophysiology (EP) monitoring. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DYB INTRODUCER, CATHETER
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DARK, DRY PLACE.
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Clinically Relevant Size

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Size Type Text
Catheter Gauge: 8.5 French
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Device Status

In Commercial Distribution
November 03, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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