DEVICE: Chiba Biopsy Needle with Echogenic Tip (00886333001842)
Device Identifier (DI) Information
Chiba Biopsy Needle with Echogenic Tip
MCN2008US
In Commercial Distribution
MCN2008US
ARGON MEDICAL DEVICES, INC.
MCN2008US
In Commercial Distribution
MCN2008US
ARGON MEDICAL DEVICES, INC.
Chiba Biopsy Needle with Echogenic Tip 20ga x 20cm
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? |
---|---|---|---|---|
47540 | Soft-tissue biopsy needle, single-use |
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNW | Instrument, Biopsy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K980122 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: keep dry and away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 20ga x 20cm |
Device Record Status
ed651390-7006-4e5b-a840-60c02f9b0711
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 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 |
---|---|---|---|---|---|
20886333001846 | 10 | 00886333001842 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
1.800.927.4669
Customer.Service@argonmedical.com
Customer.Service@argonmedical.com