OPTRELL D140901
GUDID 10846835023015
Mapping Catheter with TRUEref Technology
Biosense Webster Inc
Cardiac mapping catheter, percutaneous, single-use| Primary Device ID | 10846835023015 |
| NIH Device Record Key | cc1a1a94-7aab-4d76-b2a0-bb142b07e75b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTRELL |
| Version Model Number | D140901 |
| Catalog Number | D140901 |
| Company DUNS | 020163218 |
| Company Name | Biosense Webster Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com | |
| Phone | +1(800)729-9010 |
| RA-BWIUS-Complaints@its.jnj.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10846835023015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211438
FDA Product Code
| DRF | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
[10846835023015]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-04 |
| Device Publish Date | 2022-03-25 |
On-Brand Devices [OPTRELL]
| 10846835023022 | Mapping Catheter with TRUEref Technology |
| 10846835023015 | Mapping Catheter with TRUEref Technology |
Trademark Results [OPTRELL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTRELL 90129044 not registered Live/Pending |
Biosense Webster, Inc. 2020-08-21 |
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