TYSHAK® 610524
GUDID 04046964330018
PDC012 10MM X 4CM BALL CATH TYSHAK STD
B BRAUN INTERVENTIONAL SYSTEMS, INC
Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter Cardiac valvuloplasty catheter| Primary Device ID | 04046964330018 |
| NIH Device Record Key | 4feee9eb-67b9-432b-aad0-451a437c23fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TYSHAK® |
| Version Model Number | 610524 |
| Catalog Number | 610524 |
| 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 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964330018 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K931009
FDA Product Code
| LIT | Catheter, angioplasty, peripheral, transluminal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-11-02 |
| Device Publish Date | 2016-08-09 |
On-Brand Devices [TYSHAK®]
| 04046964335501 | SO010 TYSHAK 13MM 3CM |
| 04046964335150 | PDC095 TYSHAK 15MM 2CM |
| 04046964333750 | PDC098 TYSHAK 13MM 5CM |
| 04046964333613 | PDC082 SP BALL CATH 25MM 5.5CM TYSHAK |
| 04046964331800 | PDC139 SPECIAL BALLOON CATH 22MM 6CM |
| 04046964331671 | PDC148 SPECIAL BALLOON CATH 12MM 2CM |
| 04046964330995 | PDC076 SPECIAL BALLOON CATH 18MM 4CM |
| 04046964330971 | PDC069 SPECIAL BALLOON CATH 8MM 8CM |
| 04046964330582 | PDC088 SPECIAL BALLOON CATH 6MM 2CM |
| 04046964330544 | PDC117 10MM X 3CM BALL CATH TYSHAK STD |
| 04046964329876 | PDC008 8MM X 3CM BALLOON CATH TYSHAK SP |
| 04046964329807 | PDC037 7MM X 4CM BALLOON CATH TYSHAK SP |
| 04046964332142 | PDC125 SPECIAL BALLOON CATH 16MM 9CM |
| 04046964332012 | PDC107 SPECIAL BALLOON CATH 14MM 4CM |
| 04046964331824 | PDC136 SPECIAL BALLOON CATH 19MM 6CM |
| 04046964555060 | PDC144 SPECIAL BALLOON CATH 16MM 6CM |
| 04046964335587 | SO015 BALLOON CATH SPEC TYSHAK 12MM 10C |
| 04046964335549 | SO012 TYSHAK BALLOON CATH 17MM 5CM |
| 04046964335105 | PDC157 SPEC BALLOON CATH TYSHAK 7MM 3C |
| 04046964334986 | PDC153 SPEC BALLOON CATH TYSHAK 14MM 5C |
| 04046964333798 | PDC100 SP BALLOON CATH 20MM 9CM TYSHAK |
| 04046964333774 | PDC099 SP BALLOON CATH 19MM 9CM TYSHAK |
| 04046964333736 | PDC097 SP BALLOON CATH 18MM 4CM TYSHAK |
| 04046964333699 | PDC087 SP BALLOON CATH 6MM 4CM TYSHAK |
| 04046964333637 | PDC083 SP BALL CATH 22MM 5.5CM TYSHAK |
| 04046964333583 | PCD065 SP BALLOON CATH 22MM 3CM TYSHAK |
| 04046964333576 | PDC050 SP BALLOON CATH 6MM 6CM TYSHAK |
| 04046964332203 | PDC128 SPECIAL BALLOON CATH 15MM 4CM |
| 04046964332166 | PDC126 SPECIAL BALLOON CATH 7MM 2CM |
| 04046964332135 | PDC124 SPECIAL BALLOON CATH 7MM 2CM |
| 04046964332111 | PDC123 SPECIAL BALLOON CATH 17MM 8CM |
| 04046964332081 | PDC122 SPECIAL BALLOON CATH 18MM 4CM |
| 04046964332074 | PDC121 SPECIAL BALLOON CATH 15MM 7CM |
| 04046964332029 | PDC108 SPECIAL BALLOON CATH 22MM 5.5CM |
| 04046964331978 | PDC130 SPECIAL BALLOON CATH 10MM 3CM |
| 04046964331954 | PDC134 SPECIAL BALLOON CATH 12MM 4CM |
| 04046964331930 | PDC133 SPECIAL BALLOON CATH 12MM 3CM |
| 04046964331879 | PDC132 SPECIAL BALLOON CATH 10MM 5CM |
| 04046964331848 | PDC138 SP BALLOON CATH 4MM 2CM TYSHAK |
| 04046964331787 | PDC141 SPECIAL BALLOON CATH 4MM 3CM |
| 04046964331749 | PDC143 SPECIAL BALLOON CATH 20MM 5.5CM |
| 04046964331701 | PDC146 SPECIAL BALLOON CATH 10MM 8CM |
| 04046964331688 | PDC147 SPECIAL BALLOON CATH 8MM 8CM |
| 04046964331657 | PDC149 SPECIAL BALLOON CATH 12MM 3CM |
| 04046964331596 | PDC053 SPECIAL BALLOON CATH 10MM 4CM |
| 04046964331534 | PDC051 SPECIAL BALLOON CATH 8MM 4CM |
| 04046964331350 | PDC104 SPECIAL BALLOON CATH 20MM 8CM |
| 04046964331336 | PDC103 SPECIAL BALLOON CATH 6MM 8CM |
| 04046964331312 | PDC102 SPECIAL BALLOON CATH 6MM 5CM |
| 04046964331275 | PDC060 SPECIAL BALLOON CATH 20MM X 10CM |
Trademark Results [TYSHAK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TYSHAK 75281664 2153776 Live/Registered |
NuMED, INC. 1997-04-24 |
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