DEVICE: Procedure Products Needle (B1605118271)
Device Identifier (DI) Information
Procedure Products Needle
51-1827
In Commercial Distribution
PROCEDURE PRODUCTS, INC.
51-1827
In Commercial Distribution
PROCEDURE PRODUCTS, INC.
Seldinger Needle, 18ga x 7cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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61502 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DRE | Dilator, Vessel, For Percutaneous Catheterization |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K810859 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
abb1c525-332b-4610-9ae6-e19f4dd97a5c
July 06, 2018
3
December 01, 2016
July 06, 2018
3
December 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined