DEVICE: Westcott Biopsy Needle with Echogenic Tip (00886333003105)

Device Identifier (DI) Information

Westcott Biopsy Needle with Echogenic Tip
MWN2006US
In Commercial Distribution
MWN2006US
ARGON MEDICAL DEVICES, INC.
00886333003105
GS1

1
140727624 *Terms of Use
Westcott Biopsy Needle with Echogenic Tip 20ga x 15cm
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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?
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.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
KNW Instrument, Biopsy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K980122 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry and Away from Sunlight
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 20ga x 15cm
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Device Record Status

80878b65-8fed-43ed-9366-4b7dd5f291c1
July 06, 2018
3
September 16, 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
20886333003109 10 00886333003105 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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