| Primary Device ID | 00816389028074 |
| NIH Device Record Key | 1ca46e3b-8585-4720-9b59-d2dd10b0a2a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Catheter flap, 200 mm x 290 mm x 10 mm |
| Version Model Number | GM11012130 |
| Catalog Number | GM11012130 |
| Company DUNS | 332474605 |
| Company Name | Varian Medical Systems Deutschland GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816389028074 [Primary] |
| JAQ | System, applicator, radionuclide, remote-controlled |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-13 |
| Device Publish Date | 2024-11-05 |
| 00816389028067 - Catheter Surface Flap Applicator Set | 2024-11-13 |
| 00816389028074 - Catheter flap, 200 mm x 290 mm x 10 mm | 2024-11-13 |
| 00816389028074 - Catheter flap, 200 mm x 290 mm x 10 mm | 2024-11-13 |
| 00810563021929 - Heyman capsule MR safe, 4 mm diameter x 17.5 mm length, with mandrin | 2024-10-31 |
| 00810563021936 - Heyman capsule MR safe, 6 mm diameter x 17.5 mm length, with mandrin | 2024-10-31 |
| 00810563021943 - Heyman capsule MR safe, 8 mm diameter x 17.5 mm length, with mandrin | 2024-10-31 |
| 00810563022834 - Intraluminal Applicator Set | 2024-10-08 Intraluminal Applicator Set |
| 10816389027180 - Protection caps, blue (pack of 20) | 2024-05-03 |
| 10816389027210 - Sterilization plug, black (pack of 25) | 2024-05-03 |