RADIFOCUS TD01
GUDID 56927675513484
Torque Device
Terumo Medical Products (Hangzhou) Co., Ltd.
Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device| Primary Device ID | 56927675513484 |
| NIH Device Record Key | f1176292-525c-49ef-9de2-7b1619917dec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RADIFOCUS |
| Version Model Number | XX*RF02AH |
| Catalog Number | TD01 |
| Company DUNS | 544830912 |
| Company Name | Terumo Medical Products (Hangzhou) Co., Ltd. |
| Device Count | 5 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06927675513489 [Unit of Use] |
| GS1 | 36927675513480 [Primary] |
| GS1 | 56927675513484 [Package] Contains: 36927675513480 Package: Large Unit box [4 Units] In Commercial Distribution |
| GS1 | 76927675513488 [Package] Package: Shipping carton [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220934
FDA Product Code
| MOF | Guide, Wire, Catheter, Neurovasculature |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-11-29 |
| Device Publish Date | 2022-12-08 |
Devices Manufactured by Terumo Medical Products (Hangzhou) Co., Ltd.
| 56927675513484 - RADIFOCUS | 2023-11-29Torque Device |
| 56927675513484 - RADIFOCUS | 2023-11-29 Torque Device |
| 56927675515396 - SURFLO | 2023-08-21 SURFLO Winged Infusion Set |
| 56927675515402 - SURFLO | 2023-08-21 SURFLO Winged Infusion Set |
| 56927675515419 - SURFLO | 2023-08-21 SURFLO Winged Infusion Set |
| 56927675515426 - SURFLO | 2023-08-21 SURFLO Winged Infusion Set |
| 56927675515372 - SURFLO | 2023-08-21 SURFLO Winged Infusion Set |
| 56927675515389 - SURFLO | 2023-08-21 SURFLO Winged Infusion Set |
| 56927675515433 - SURFLO | 2023-08-21 SURFLO Winged Infusion Set |
Trademark Results [RADIFOCUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RADIFOCUS 73633375 1459954 Live/Registered |
TERUMO KABUSHIKI KAISHA 1986-12-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.