DEVICE: ATEC Needle Guide (05420045503116)
Device Identifier (DI) Information
ATEC Needle Guide
ATEC NG09-FISCH
In Commercial Distribution
ATEC NG09-FISCH
Hologic, Inc.
ATEC NG09-FISCH
In Commercial Distribution
ATEC NG09-FISCH
Hologic, Inc.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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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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58990 | Side-notch biopsy gun handpiece/needle |
A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small 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, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. 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 |
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KNW | INSTRUMENT, BIOPSY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K042290 | 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
748d15ce-1861-4df1-8a0c-a261299b0811
July 12, 2019
4
September 03, 2015
July 12, 2019
4
September 03, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
15420045503113 | 5 | 05420045503116 | 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
[?]
No Customer Contact currently defined