| Primary Device ID | 27290110066516 |
| NIH Device Record Key | d7f83864-9cae-4922-ab78-7f7e15b61e16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Covidien AG |
| Version Model Number | 102201101680TY |
| Company DUNS | 600007082 |
| Company Name | DEGANIA SILICONE LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | true |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290110066512 [Primary] |
| GS1 | 27290110066516 [Package] Contains: 07290110066512 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 47290110066510 [Package] Package: Carton [10 Units] In Commercial Distribution |
| EZL | Catheter, Retention Type, Balloon |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
[27290110066516]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-12 |
| Device Publish Date | 2025-03-04 |
| 27290110066523 | TSC 18Fr Blue Tip F400(+/-0.1) Sterile |
| 27290110066509 | TSC 14Fr Blue Tip F400(+/-0.1) Sterile |
| 27290110066493 | TSC CATHETER CLEAR 12FR STERILE |
| 27290110066486 | TSC 10Fr Blue Tip F400(+/-0.1) Sterile |
| 27290110066479 | TSC 8Fr Blue Tip F400(+/-0.1) Sterile |
| 27290110066516 | TSC 16Fr Blue Tip F400(+/-0.1) Sterile |