Primary Device ID | 18719867002643 |
NIH Device Record Key | 26d93c8d-478f-4bb8-8d0d-1421ca884ed2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Mistral-Air® |
Version Model Number | MA2455-PM |
Company DUNS | 409656493 |
Company Name | The Surgical Company International B.V. |
Device Count | 1 |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08719867002646 [Primary] |
GS1 | 18719867002643 [Package] Contains: 08719867002646 Package: [40 Units] In Commercial Distribution |
DWJ | System, Thermal Regulating |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-16 |
Device Publish Date | 2024-07-08 |
18719867002667 | Mistral-Air® Premium Lithotomy - SYK |
18719867002643 | Mistral-Air® Lithotomy Plus - SYK |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MISTRAL-AIR 85186399 4008906 Live/Registered |
The Surgical Company International B.V. 2010-11-29 |
![]() MISTRAL-AIR 79062248 not registered Dead/Abandoned |
The Surgical Company International B.V. 2008-09-19 |