Primary Device ID | 00857042007432 |
NIH Device Record Key | 90cfa67e-8b24-4f60-a439-b8ef1543fae6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AcQGuide |
Version Model Number | 112852 |
Company DUNS | 844418199 |
Company Name | ACUTUS MEDICAL, 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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00857042007432 [Primary] |
DYB | Introducer, Catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-08-01 |
Device Publish Date | 2019-07-24 |
00857042007012 | AcQGuide® Steerable Sheath |
00857042007456 | AcQGuide Flex 65 cm Med Curl with AcQCross QX |
00857042007432 | AcQGuide Mini 65cm - L2 with AcQCross QX |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACQGUIDE 87246283 5308281 Live/Registered |
Acutus Medical, Inc. 2016-11-23 |