DEVICE: Manan Medical Products, Inc. (00859013006185)

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Device Identifier (DI) Information

Manan Medical Products, Inc.
GWI20015EWW
GWI20015EWW
MANAN MEDICAL PRODUCTS, INC.
00859013006185
GS1
1
Guide Wire Introducer Needle With Window Wall Hub 20GA X 1.5"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
Vascular catheter introduction needle A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DWS Instruments, Surgical, Cardiovascular
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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

[?]
Size Type Text
Length: 1.5 Inch
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Device Status

In Commercial Distribution
October 26, 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
20859013006189 10 10859013006182 In Commercial Distribution Unit Boxes
10859013006182 10 00859013006185 In Commercial Distribution Tyvek Pouch
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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

[?]
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

[?]
224-625-8331
David.Gasparik@argonmedical.com
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