DEVICE: Fiberlink transmitter (07090042055017)

Device Identifier (DI) Information

Fiberlink transmitter
FLT 2.1
In Commercial Distribution

Nordicneurolab AS
07090042055017
GS1

1
671280238 *Terms of Use
Fiberlink transmitter is part of NordicNeuroLab’s fMRI System. Fiberlink transmitter converts audio and video signals into an optical signal for transmission. Fiberlink transmitter is used togheter with NordicNeuroLab’s Visual System and Audio System.
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Device Characteristics

MR Unsafe
No
No
No
No
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
Laser adaptor A connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
LNH System, Nuclear Magnetic Resonance Imaging
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K092253 000
No CLOSE

Sterilization

No
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
No Device Sizes
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Device Record Status

538c33d6-9f16-4fe9-bac7-ce7203b8dd57
July 06, 2018
3
September 24, 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
No Package DIs found
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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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+4755707095
customerservice@nordicneurolab.com
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