DEVICE: RELI (00386120008608)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
RELI
R-MRN2115
In Commercial Distribution
R-MRN2115
MYCO MEDICAL SUPPLIES INC.
00386120008608
GS1

1
879187821 *Terms of Use
MAMMOREP N® Breast localization needle, simple hook-wire 21G x 15cm
CLOSE

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?
47020 Imaging lesion localization marker, external, single-use
A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KNW Instrument, Biopsy
FCG Biopsy Needle
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K051506 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 15 Centimeter
Needle Gauge: 21 Gauge
CLOSE

Device Record Status
6ddd4181-9234-46ce-befa-664e70319bcf
October 12, 2018
1
September 11, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10386120008605 25 00386120008608 In Commercial Distribution Inner Carton
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE