DEVICE: MammoStar™ (00858015005356)

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Device Identifier (DI) Information

MammoStar™
STAR1001
STAR1001
Carbon Medical Technologies, Inc.
00858015005356
GS1
1
Biopsy Site Identifier
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Device Characteristics

MR Safe
No
Yes
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
Imaging lesion localization marker, implantable A sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
NEU Marker, Radiographic, Implantable
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Sterilization

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

[?]
Storage and Handling
Handling Environment Temperature: between 60 and 90 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Length: 17 Millimeter
Outer Diameter: 2 Millimeter
Device Size Text, specify: Biopsy Probe Inner Diameter; 2.5 millimeter
Needle Gauge: 10 Gauge
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Device Status

In Commercial Distribution
September 24, 2015

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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
10858015005353 10 00858015005356 In Commercial Distribution Carton
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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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8882070262
info@carbonmed.com
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