DEVICE: NeoMagic (B339914080)

Device Identifier (DI) Information

NeoMagic
914-08
In Commercial Distribution
914-08
NEO MEDICAL INC.
B339914080
HIBCC

1
015510540 *Terms of Use
Repositioning Deflection .008" x 60cm Hydrophillic Coated Wire
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Device Characteristics

MR Unsafe
No
Yes
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
Peripheral vascular guidewire, manual A long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
KZH Introducer, Syringe Needle
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K951384 000
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: Keep Dry
Special Storage Condition, Specify: Keep Away From Sunlight
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Clinically Relevant Size

[?]
Size Type Text
Length: 60 Centimeter
Outer Diameter: .008 Inch
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Device Record Status

2dd41a2c-303d-4503-bf02-2d6d0cfc0b6b
July 06, 2018
3
September 24, 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
B339914085 5 B339914080 In Commercial Distribution Case
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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

[?]
888-450-3334
support@neomedicalinc.com
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