DEVICE: MaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle (00886333002863)
Device Identifier (DI) Information
MaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle
MMCI2206US
In Commercial Distribution
MMCI2206US
ARGON MEDICAL DEVICES, INC.
MMCI2206US
In Commercial Distribution
MMCI2206US
ARGON MEDICAL DEVICES, INC.
MaxiCell™ Biopsy Needle with Echogenic Tip Introducer Needle
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: MaxiCell™ Biopsy Needle: 22ga x 15cm, Introducer Needle: 19ga x 11.4cm |
Device Record Status
d0b8b44b-4fc7-48aa-9179-f99342288bd1
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 |
---|---|---|---|---|---|
20886333002867 | 10 | 00886333002863 | 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