DEVICE: Medistar/Hatch (Private Label) (00859013006031)

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Device Identifier (DI) Information

Medistar/Hatch (Private Label)
FNM-2205-UG
FNM-2205-UG
MANAN MEDICAL PRODUCTS, INC.
00859013006031
GS1
1
22GA RW X 5 CM (CALIBRATED FRANSEEN WITH ECHOGENIC TIP)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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 hsitopathological 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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FDA Product Code

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Product Code Product Code Name
KNW Instrument, Biopsy
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 5 Centimeter
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Device Status

In Commercial Distribution
October 14, 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
20859013006035 10 10859013006038 In Commercial Distribution Unit Boxes
10859013006038 10 00859013006031 In Commercial Distribution Tyvek Pouch
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Secondary DI

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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

[?]
No Customer Contact currently defined
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