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 Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag 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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