DEVICE: FibermarX (00850016008008)

Device Identifier (DI) Information

FibermarX
60004
In Commercial Distribution
60004
Viscus Biologics LLC
00850016008008
GS1

1
031183936 *Terms of Use
FibermarX Radiopaque Tissue Marker
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Device Characteristics

MR Safe
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?
40808 Radiological image marker, implantable
A 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 in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, 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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NEU Marker, Radiographic, Implantable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K170026 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 36 Inch
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Device Record Status

1e1e5aad-c0b9-4ee8-8401-032ebdab1a23
September 18, 2023
6
January 18, 2018
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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
00850016008015 5 00850016008008 In Commercial Distribution Carton
00850016008022 10 00850016008015 In Commercial Distribution Case
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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
No
No CLOSE

Customer Contact

[?]
2167442744
justin.baker@viscusbiologics.com
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