StabilICE 900218
GUDID 00850027837529
StabilICE
ACUTUS MEDICAL, INC.
General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use| Primary Device ID | 00850027837529 |
| NIH Device Record Key | 4a3dc281-3b2b-482b-9933-dcde139aaf9c |
| 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850027837529 [Primary] |
FDA Product Code
| HYA | Forceps, Wire Holding |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
[00850027837529]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-05 |
| Device Publish Date | 2021-10-28 |
On-Brand Devices [StabilICE]
| 00850027837529 | StabilICE |
| 00850027837659 | StabilICE |
| 00850027837642 | StabilICE |
Trademark Results [StabilICE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STABILICE 97434132 not registered Live/Pending |
Evans, Simon, Andrew 2022-05-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.