Primary Device ID | 00842071109899 |
NIH Device Record Key | 1446cf31-40ee-471b-9886-0e396b85228e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Abeon Remora Smoke and Fluid Evacuation System |
Version Model Number | ST9000 |
Company DUNS | 038101861 |
Company Name | APPLIED MEDICAL TECHNOLOGY, INC. |
Device Count | 10 |
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 |
Phone | (440) 717-4000 |
cs@appliedmedical.net |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00842071109332 [Unit of Use] |
GS1 | 00842071109899 [Primary] |
GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-23 |
00842071132040 - Non-Balloon Removal Tool | 2024-06-24 14F x 1.0-1.2cm Non-Balloon Removal Tool (MDR) |
00842071132057 - Non-Balloon Removal Tool | 2024-06-24 14F x 1.5-1.7cm Non-Balloon Removal Tool (MDR) |
00842071132064 - Non-Balloon Removal Tool | 2024-06-24 14F x 2.0-2.3cm Non-Balloon Removal Tool (MDR) |
00842071132071 - Non-Balloon Removal Tool | 2024-06-24 14F x 2.4-2.7cm Non-Balloon Removal Tool (MDR) |
00842071132088 - Non-Balloon Removal Tool | 2024-06-24 14F x 3.0-3.3cm Non-Balloon Removal Tool (MDR) |
00842071132095 - Non-Balloon Removal Tool | 2024-06-24 18-24F x 1.0-1.2cm Non-Balloon Removal Tool (MDR) |
00842071132101 - Non-Balloon Removal Tool | 2024-06-24 18-24F x 1.5-1.7cm Non-Balloon Removal Tool (MDR) |
00842071132118 - Non-Balloon Removal Tool | 2024-06-24 18-24F x 2.0-2.3cm Non-Balloon Removal Tool (MDR) |