Primary Device ID | EFIAE0131042 |
NIH Device Record Key | 26c6d445-9d3e-4e1d-ac89-e5a71e2cc464 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FlexTube 3 single use |
Version Model Number | 1 |
Company DUNS | 312623008 |
Company Name | Fiagon GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | EFIAE0131041 [Primary] |
HIBCC | EFIAE0131042 [Package] Contains: EFIAE0131041 Package: [5 Units] In Commercial Distribution |
HIBCC | EFIAE0131043 [Package] Contains: EFIAE0131041 Package: [20 Units] In Commercial Distribution |
HIBCC | EFIAE0131044 [Package] Contains: EFIAE0131041 Package: [40 Units] In Commercial Distribution |
PGW | Ear, Nose, And Throat Stereotaxic Instrument |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-06-21 |
Device Publish Date | 2021-06-11 |
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04260759930386 - PointerShell 3 mm | 2024-09-10 The device PointerShell 3mm is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 3.4mm. |
04260759930393 - PointerShell Universal | 2024-09-10 The device PointerShell Universal is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 5 |
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