DEVICE: ZIPwire™ (08714729763895)

Device Identifier (DI) Information

ZIPwire™
M00146151B0
In Commercial Distribution
M00146151B0
Lake Region Medical
08714729763895
GS1

1
031108704 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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?
58115 Peripheral vascular guidewire, manual
A long, thin 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DQX Wire, Guide, Catheter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K000011 000
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry, dark place.
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: .035 Inch
Length: 150 Centimeter
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Device Record Status

91cce5a5-c9a0-4044-b75a-55a52bddd3a6
June 26, 2024
5
November 01, 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
08714729754695 5 08714729763895 In Commercial Distribution
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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

[?]
No Customer Contact currently defined
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