RADIFOCUS TD01
GUDID 56927675513484
Torque Device
Terumo Medical Products (Hangzhou) Co., Ltd.
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.
| 06927675519870 - TR Band | 2024-09-09 TR Band Radial Artery Compression Device |
| 56927675519882 - TR Band | 2024-09-09 TR Band Radial Artery Compression Device |
| 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 |
Trademark Results [RADIFOCUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RADIFOCUS 73633375 1459954 Live/Registered |
TERUMO KABUSHIKI KAISHA 1986-12-03 |
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