SMARTABLATE D130302
GUDID 10846835012637
BIOSENSE WEBSTER INC.
Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable| Primary Device ID | 10846835012637 |
| NIH Device Record Key | 93a1e0e5-b458-4fca-95e5-25737c5ce78a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SMARTABLATE |
| Version Model Number | D130302 |
| Catalog Number | D130302 |
| Company DUNS | 020163218 |
| Company Name | BIOSENSE WEBSTER 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 | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10846835012637 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P990071
FDA Product Code
| LPB | Cardiac ablation percutaneous catheter |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
[10846835012637]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-01-15 |
| Device Publish Date | 2018-06-01 |
On-Brand Devices [SMARTABLATE]
| 10846835012644 | D130303 |
| 10846835012637 | D130302 |
| 10846835009743 | SAT001 |
Trademark Results [SMARTABLATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMARTABLATE 85109962 4537964 Live/Registered |
BIOSENSE WEBSTER, INC. 2010-08-18 |
 SMARTABLATE 77703341 not registered Dead/Abandoned |
Cordis Corporation 2009-03-31 |
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