| Primary Device ID | B887GF10010 |
| NIH Device Record Key | c0525d5f-1835-4c0a-a538-bc0c02006813 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VISICOIL MR |
| Version Model Number | GF1001 |
| Catalog Number | GF1001 |
| 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 | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com | |
| Phone | +1 901-432-7202 |
| VISICOIL@izimed.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B887GF10010 [Primary] |
| JAK | System, X-Ray, Tomography, Computed |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
Ethylene Oxide
[B887GF10010]
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 |
| EIBASNMR05001021200 | 0.50mm x 01.0cm VISICOIL MR Platinum loaded in an 21 gauge 20cm pre-waxed needle. |
| EIBASNMR05001021150 | 0.50mm x 01.0cm VISICOIL MR Platinum loaded in an 21 gauge 15cm pre-waxed needle. |
| EIBASNMR05000521200 | 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 20cm pre-waxed needle |
| EIBASNMR05000521150 | 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 15cm pre-waxed needle. |
| EIBASNMR05000521080 | 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 8cm pre-waxed needle. |
| EIBASNMR03503022200 | 0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. |
| EIBASNMR03502022200 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. |
| EIBASNMR03502022150 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. |
| EIBASNMR03502022080 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. |
| EIBASNMR03501022200 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. |
| EIBASNMR03501022150 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. |
| EIBASNMR03501022080 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. |
| EIBASNMR03500522200 | 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22g 20cm pre-waxed needle. |
| EIBASNMR03500522150 | 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22g 15cm pre-waxed needle. |
| EIBASNMR03500522080 | 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22 gauge 8cm pre-waxed needle. |
| EIBAMRFP1000200 | 1.00 mm x 2.0 cm VISICOIL MR Platinum Fiducial Tissue Marker |
| EIBAMRFP1000100 | 1.00 mm x 1.0 cm VISICOIL MR Fiducial Tissue Marker |
| EIBAMRFP1000050 | 1.00 mm x 0.5 cm VISICOIL MR Fiducial Tissue Marker |
| EIBAMRFP0750200 | 0.75 mm x 2.0 cm VISICOIL MR Platinum Fiducial Tissue Marker |
| EIBAMRFP0750100 | 0.75 mm x 1.0 cm VISICOIL MR Fiducial Tissue Marker |
| EIBAMRFP0750050 | 0.75 mm x 0.5 cm VISICOIL MR Fiducial Tissue Marker |
| EIBAMRFP0500200 | 0.50 mm x 2 cm VISICOIL MR Platinum Fiducial Tissue Marker |
| EIBAMRFP0500100 | 0.50 mm x 1 cm VISICOIL MR Fiducial Tissue Marker |
| EIBAMRFP0500050 | 0.50 mm x 0.5 cm VISICOIL MR Fiducial Tissue Marker |
| EIBAMRFP0350200 | 0.35 mm x 2 cm VISICOIL MR Platinum Fiducial Tissue Marker |
| EIBAMRFP0350100 | 0.35 mm x 1 cm VISICOIL MR Fiducial Tissue Marker |
| EIBAMRFP0350050 | 0.35 mm x 0.5 cm VISICOIL MR Fiducial Tissue Marker |
| EIBAMR075010PL0 | 0.75mm x 1.0cm VISICOIL MR Platinum loaded in a 19 gauge 20cm pre-waxed needle |
| EIBAMR075005PL0 | 0.75mm x 0.5cm VISICOIL MR Platinum loaded in a 19 gauge 20cm pre-waxed needle |
| EIBAMR050010PL0 | 0.50mm x 1.0cm VISICOIL MR Platinum loaded in a 20 gauge 20cm pre-waxed needle |
| EIBAMR050005PL0 | 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 20 gauge 20cm pre-waxed needle |
| EIBAMR005005PL0 | 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 20 gauge 20cm pre-waxed needle |
| B887SNMR05001021200 | 0.50mm x 01.0cm VISICOIL MR Platinum loaded in an 21 gauge 20cm pre-waxed needle. |
| B887SNMR05001021150 | 0.50mm x 01.0cm VISICOIL MR Platinum loaded in a 21 gauge 15cm pre-waxed needle. |
| B887SNMR05000521150 | 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 15cm pre-waxed needle. |
| B887SNMR05000521080 | 0.50mm x 0.5cm VISICOIL MR Platinum loaded in an 21 gauge 8cm pre-waxed needle. |
| B887SNMR03503022200 | 0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. |
| B887SNMR03502022200 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. |
| B887SNMR03502022150 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. |
| B887SNMR03502022080 | 0.35mm x 2.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. |
| B887SNMR03501022200 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. |
| B887SNMR03501022150 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded in an 22 gauge 15cm pre-waxed brachytherapy needle. |
| B887SNMR03501022080 | 0.35mm x 1.0cm VISICOIL MR Platinum loaded into a pre-waxed 22 gauge 8cm needle. |
| B887SNMR03500522200 | 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22g 20cm pre-waxed needle. |
| B887SNMR03500522150 | 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22g 15cm pre-waxed needle. |
| B887SNMR03500522080 | 0.35mm x 0.5cm VISICOIL MR Platinum loaded into an 22 gauge 8cm pre-waxed needle. |
| B887MRFP1000200 | 1.00 mm x 2.0 cm VISICOIL MR Platinum Fiducial Tissue Marker |
| B887MRFP1000100 | 1.00 mm x 1.0 cm VISICOIL MR Fiducial Tissue Marker |
| B887MRFP1000050 | 1.00 mm x 0.5 cm VISICOIL MR Fiducial Tissue Marker |
| B887MRFP0750200 | 0.75 mm x 2.0 cm VISICOIL MR Platinum Fiducial Tissue Marker |