DEVICE: Vessel Dilator (00886333210411)

Device Identifier (DI) Information

Vessel Dilator
392309
In Commercial Distribution
392309
ARGON MEDICAL DEVICES, INC.
00886333210411
GS1

1
140727624 *Terms of Use
Vessel Dilator 9 French
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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?
46448 Fascial tissue dilator, single-use
A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRE Dilator, Vessel, For Percutaneous Catheterization
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K780126 000
No 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: 9 French
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Device Record Status

cfb68d92-6668-4963-aaf0-f90c7838d307
July 06, 2018
3
September 10, 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
10886333210418 10 00886333210411 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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