AcQGuide 900002
GUDID 00857042007012
AcQGuide® Steerable Sheath
ACUTUS MEDICAL, INC.
Vascular guide-catheter, single-use| Primary Device ID | 00857042007012 |
| NIH Device Record Key | bc8028c7-cbab-46ef-96c0-c076bfb4ee99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcQGuide |
| Version Model Number | 900002 |
| Catalog Number | 900002 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857042007012 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162925
FDA Product Code
| DRA | Catheter, Steerable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2018-02-15 |
On-Brand Devices [AcQGuide]
| 00857042007012 | AcQGuide® Steerable Sheath |
| 00857042007456 | AcQGuide Flex 65 cm Med Curl with AcQCross QX |
| 00857042007432 | AcQGuide Mini 65cm - L2 with AcQCross QX |
Trademark Results [AcQGuide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACQGUIDE 87246283 5308281 Live/Registered |
Acutus Medical, Inc. 2016-11-23 |
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