Impact™ 122120
GUDID 04046964290510
IMPACT BALLOON CATHETER 12MMX2CMX120CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 04046964290510 |
| NIH Device Record Key | 2901c70c-0a9e-4d99-a017-76cd73eca05a |
| Commercial Distribution Discontinuation | 2021-08-04 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Impact™ |
| Version Model Number | 122120 |
| Catalog Number | 122120 |
| 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 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| 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 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964290510 [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 | 6 |
| Public Version Date | 2021-08-06 |
| 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]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMPACT 98601500 not registered Live/Pending |
Marli J. Washington 2024-06-14 |
 IMPACT 98528216 not registered Live/Pending |
L'Chef, LLC 2024-04-30 |
 IMPACT 98528203 not registered Live/Pending |
L'Chef, LLC 2024-04-30 |
 IMPACT 98502001 not registered Live/Pending |
Hornady Manufacturing Company 2024-04-16 |
 IMPACT 98384931 not registered Live/Pending |
HCMP, Inc. 2024-01-31 |
 IMPACT 98328305 not registered Live/Pending |
The Impact Fund 2023-12-22 |
 IMPACT 98328269 not registered Live/Pending |
Indian American Impact 2023-12-22 |
 IMPACT 98299820 not registered Live/Pending |
NOBULL, LLC 2023-12-05 |
 IMPACT 98285346 not registered Live/Pending |
Lazarex Cancer Foundation 2023-11-26 |
 IMPACT 98277080 not registered Live/Pending |
Montage Hotels & Resorts, LLC 2023-11-19 |
 IMPACT 98189133 not registered Live/Pending |
Alveo Technologies Inc. 2023-09-20 |
 IMPACT 98090236 not registered Live/Pending |
MedTech Global Products LLC 2023-07-18 |
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