DEVICE: BioPince™ Full Core Biopsy Instrument (00886333004355)
Device Identifier (DI) Information
BioPince™ Full Core Biopsy Instrument
360-1580-01
In Commercial Distribution
360-1580-01
ARGON MEDICAL DEVICES, INC.
360-1580-01
In Commercial Distribution
360-1580-01
ARGON MEDICAL DEVICES, INC.
BioPince™ Full Core Biopsy Instrument 18G x 15cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
No | |
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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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22726 | End-cut biopsy gun handpiece/needle |
A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNW | Instrument, Biopsy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K904987 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep Dry and Away from Sunlight |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 18G x 15cm |
Device Record Status
dac9f525-9d2e-48f7-80d2-6ba7e31dc178
July 12, 2019
4
September 01, 2016
July 12, 2019
4
September 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 |
---|---|---|---|---|---|
20886333004359 | 5 | 00886333004355 | In Commercial Distribution | Box |
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
[?]
1.800.927.4669
Customer.Service@argonmedical.com
Customer.Service@argonmedical.com