PneumoLiner
GUDID 05391530440011
The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparosco
ADVANCED SURGICAL CONCEPTS LIMITED
Tissue extraction bag| Primary Device ID | 05391530440011 |
| NIH Device Record Key | 41657aa5-937e-427a-93f0-bee87c2a9b47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PneumoLiner |
| Version Model Number | WA90500US |
| Company DUNS | 989586482 |
| Company Name | ADVANCED SURGICAL CONCEPTS LIMITED |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391530440004 [Primary] |
| GS1 | 05391530440011 [Package] Contains: 05391530440004 Package: CARTON OF 5 [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN150028
FDA Product Code
| PMU | Containment System, Laparoscopic Power Morcellation, With Instrument Port |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-19 |
Devices Manufactured by ADVANCED SURGICAL CONCEPTS LIMITED
| 05391530440134 - Guardenia | 2021-12-17 The Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and/o |
| 05391530440011 - PneumoLiner | 2018-07-06The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparosco |
| 05391530440011 - PneumoLiner | 2018-07-06 The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive |
| 05391530440066 - TriPort+ | 2018-07-06 This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery. T |
| 05391530440097 - TriPort15 | 2018-07-06 This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery. T |
| 05391530440103 - QuadPort+ | 2018-07-06 This device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic sur |
Trademark Results [PneumoLiner]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PNEUMOLINER 86646099 5069576 Live/Registered |
Advance Surgical Concepts Limited 2015-05-29 |
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