DEVICE: NA (06948806356034)

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Device Identifier (DI) Information

NA
S08574LL
S08574LL
Synaptic Medical, Ltd.
06948806356034
GS1
1
Steerable Intracardiac Catheter Introducer Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
Transseptal access system An assembly of devices used to puncture the interatrial septum during a transseptal catheterization procedure and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It typically includes a guidewire to facilitate the advancement of the assembled device, a sheath as the conduit, a dilator with a curved distal portion to accommodate positioning against the atrial septum, a luminal needle to create the puncture (e.g., for fluid aspiration and injection/infusion, blood sampling, pressure monitoring), and a stylet to support the needle during handling. This is a single-use device.
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FDA Product Code

[?]
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

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

[?]
Size Type Text
Catheter Gauge: 8.5 French
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Device Status

In Commercial Distribution
November 15, 2016

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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

[?]
+861051297209
service@synapticmed.com.cn
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