| Primary Device ID | B887GF15010 |
| NIH Device Record Key | 2e98e9c2-5297-41c6-a7e3-fb64d3e411db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gold Fiducial |
| Version Model Number | GF1501 |
| Catalog Number | GF1501 |
| Company DUNS | 036545713 |
| Company Name | RADIOMED CORP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
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| Phone | +1 901-432-7202 |
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| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B887GF15010 [Primary] |
| JAK | System, X-Ray, Tomography, Computed |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
[B887GF15010]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-27 |
| Device Publish Date | 2021-09-17 |
| B887GF1501 | 3 Pack - 1.0mm x 5mm Gold Fiducial Marker Loose |
| B887GF15010 | 1.0mm x 5mm Gold Fiducial Marker Loose |
| B887GF03033 | 3 Pack, 0.8mm x 3mm Gold Fiducial Marker Loose |
| B887GF03020 | 0.8mm x 3mm Gold Fiducial Marker Loose |
| B887GF10040 | 4 Pack - 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle. |
| B887GF10030 | 3 Pack - 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle. |
| B887GF15030 | 3 Pack - 1.0mm x 5mm Gold Fiducial Marker Loose |
| B887GF13230 | 3 Pack - 1.0mm x 3mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle. |
| B887GF03030 | 3 Pack, 0.8mm x 3mm Gold Fiducial Marker Loose |
| B887GF18230 | 3 Pack 1.0mm x 5mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle. |
| B887GF15340 | 4 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. |
| B887GF15330 | 3 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. |
| B887GF15310 | 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. |
| B887GF15240 | 4 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle. |
| B887GF15230 | 3 Pack 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle. |
| B887GF15210 | 1.2mm x 5mm Gold Fiducial Marker Pre-Loaded in a 17g x 20cm Needle. |
| B887GF13340 | 4 Pack 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. |
| B887GF13330 | 3 Pack 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. |
| B887GF13310 | 1.2mm x 3mm Gold Fiducial Marker Pre-Loaded in a 17g x 30cm Needle. |
| B887GF13240 | 4 Pack - 1.0mm x 3mm Gold Fiducial Marker Pre-Loaded in a 18g x 20cm Needle. |