Primary Device ID | 00850027837659 |
NIH Device Record Key | 1d9a7541-238b-4ab0-833a-b6a59f3d28b7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | StabilICE |
Version Model Number | 900218 |
Catalog Number | 900218 |
Company DUNS | 844418199 |
Company Name | ACUTUS MEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com | |
Phone | (442)232-6100 |
product.complaints@acutus.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850027837529 [Previous] |
GS1 | 00850027837659 [Primary] |
HYA | Forceps, Wire Holding |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
[00850027837659]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-04-11 |
Device Publish Date | 2022-04-01 |
00850027837529 | StabilICE |
00850027837659 | StabilICE |
00850027837642 | StabilICE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() STABILICE 97434132 not registered Live/Pending |
Evans, Simon, Andrew 2022-05-30 |