Impact™ 124750
GUDID 04046964290534
IMPACT BALLOON CATHETER 12 4 STD
B BRAUN INTERVENTIONAL SYSTEMS, INC
Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic| Primary Device ID | 04046964290534 |
| NIH Device Record Key | 10465424-ff30-4446-9fe9-48c7a65e9e1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Impact™ |
| Version Model Number | 124750 |
| Catalog Number | 124750 |
| Company DUNS | 784259751 |
| Company Name | B BRAUN INTERVENTIONAL SYSTEMS, INC |
| Device Count | 1 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964290534 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K931009
FDA Product Code
| KNQ | Dilator, esophageal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-11-02 |
| Device Publish Date | 2016-08-09 |
On-Brand Devices [Impact™]
| 04046964325830 | IMPACT 20MMX2CMX120CM |
| 04046964291173 | IMPACT BALLOON CATHETER 18MMX2CMX120CM |
| 04046964290510 | IMPACT BALLOON CATHETER 12MMX2CMX120CM |
| 04046964291388 | IMPACT 25MMX4CMX75C |
| 04046964291371 | IMPACT 25MMX4CMX120CM |
| 04046964291364 | IMPACT 25MMX2CMX75CM |
| 04046964291357 | IMPACT 25MMX2CMX120CM |
| 04046964291340 | IMPACT 22MMX4CMX75CM |
| 04046964291333 | IMPACT 22MMX4CMX120CM |
| 04046964291326 | IMPACT 22MMX2CMX75CM |
| 04046964291319 | IMPACT 22MMX2CMX120CM |
| 04046964291302 | IMPACT 20MMX4CMX75CM |
| 04046964291272 | IMPACT 20MMX4CM120CM |
| 04046964291241 | IMPACT 20MMX2CMX75CM |
| 04046964291203 | IMPACT 18MMX4CMX75CM |
| 04046964291197 | IMPACT 18MMX4CMX120CM |
| 04046964291180 | IMPACT 18MMX2CMX75CM |
| 04046964291135 | IMPACT 16MMX4CM75CM |
| 04046964291128 | IMPACT 16MMX4CMX120CM |
| 04046964291111 | IMPACT 16MMX2CMX75CM |
| 04046964290848 | IMPACT 14MMX4CMX75CM |
| 04046964290831 | IMPACT 14MMX4CMX120CM |
| 04046964290763 | IMPACT BALLOON CATHETER 14MMX2CMX120CM |
| 04046964290534 | IMPACT BALLOON CATHETER 12 4 STD |
| 04046964290527 | IMPACT BALLOON CATHETER 12 4 STD |
Trademark Results [Impact]
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