Bouncer MOB-15
GUDID 00827002268401
Bouncer Multi-path Occlusion Balloon
COOK INCORPORATED
Biliary stone retrieval balloon catheter| Primary Device ID | 00827002268401 |
| NIH Device Record Key | a88d7485-00b2-4693-9833-a39389b2aa88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bouncer |
| Version Model Number | G26840 |
| Catalog Number | MOB-15 |
| Company DUNS | 079720472 |
| Company Name | COOK INCORPORATED |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| 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 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002268401 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K953951
FDA Product Code
| GCA | CATHETER, BILIARY, SURGICAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by COOK INCORPORATED
| 10827002496535 - Cotton-Leung Sof-Flex | 2025-03-03 Cotton-Leung Sof-Flex Biliary Stent |
| 00827002352674 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352681 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352698 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352704 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 00827002352711 - Hercules | 2024-12-23 Hercules 100 Transnasal Esophageal Balloon |
| 10827002346014 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
| 10827002346939 - Fusion | 2024-08-07 Fusion Omni Preloaded with Acrobat Wire Guide |
Trademark Results [Bouncer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BOUNCER 87860024 not registered Live/Pending |
Unchained Labs 2018-04-02 |
 BOUNCER 87484241 5466186 Live/Registered |
Bouncer LLC 2017-06-12 |
 BOUNCER 87484228 5378865 Live/Registered |
Bouncer LLC 2017-06-12 |
 BOUNCER 87324708 5276245 Live/Registered |
Bouncer LLC 2017-02-04 |
 BOUNCER 86097420 not registered Dead/Abandoned |
Zhao, Jing 2013-10-22 |
 BOUNCER 85632340 not registered Dead/Abandoned |
Atomic Television, Inc. 2012-05-22 |
 BOUNCER 85535452 4260438 Dead/Cancelled |
IVANTI, INC. 2012-02-07 |
 BOUNCER 78958759 not registered Dead/Abandoned |
Phi-Cam LLC 2006-08-23 |
 BOUNCER 78818230 not registered Dead/Abandoned |
Monumental Marketing Inc. 2006-02-17 |
 BOUNCER 77827789 not registered Dead/Abandoned |
Telebrands Corp. 2009-09-16 |
 BOUNCER 77551894 not registered Dead/Abandoned |
Media Underground, Inc. 2008-08-20 |
 BOUNCER 77454753 not registered Dead/Abandoned |
TruTouch Technologies, Inc. 2008-04-22 |
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