DEVICE: Percutaneous Micro-Introducer Kit (00886333214990)

Device Identifier (DI) Information

Percutaneous Micro-Introducer Kit
497801
In Commercial Distribution
497801
ARGON MEDICAL DEVICES, INC.
00886333214990
GS1

1
140727624 *Terms of Use
4F Percutaneous Micro-Introducer Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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?
46488 Magnetocardiography system
An assembly of devices used to non-invasively detect, measure, and display bio-magnetic signals produced by electrically-active neural tissue of the heart that provide diagnostic information about cardiac electrophysiology (EP) [magnetocardiography (MCG)]. It typically consists of a fixed or moveable gantry, a patient table, a dewar [vessel containing liquid helium (He)], dedicated software, and a superconducting quantum interference device (SQUID) sensor array that measures the magnetic fields created by electrical current flowing with neurons. It may be sited within a magnetically-shielded room (MSR), and is used for cardiac mapping and the diagnosis of heart disorders.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OFL Percutaneous Sheath Introducer Kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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: 4F
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Device Record Status

0a37c8b4-f8e0-4bd0-bb8b-ce4807c34755
March 29, 2018
2
September 09, 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
10886333214997 10 00886333214990 In Commercial Distribution Box
20886333214994 50 00886333214990 In Commercial Distribution Box
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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

[?]
1.800.927.4669
Customer.Service@argonmedical.com
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