DEVICE: SecurMark for ATEC (05420045503420)
Device Identifier (DI) Information
SecurMark for ATEC
SMARK-ATEC-2S-13-09
In Commercial Distribution
SMARK-ATEC-2S-13-09
Hologic, Inc.
SMARK-ATEC-2S-13-09
In Commercial Distribution
SMARK-ATEC-2S-13-09
Hologic, Inc.
No description.
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
No | |
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NEU | MARKER, RADIOGRAPHIC, IMPLANTABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K072913 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
fa78231d-d12e-49d0-9da0-ad93c349790d
September 18, 2023
5
August 29, 2015
September 18, 2023
5
August 29, 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 |
---|---|---|---|---|---|
15420045503427 | 10 | 05420045503420 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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