DEVICE: ROS-F (00814005025186)
Device Identifier (DI) Information
Device Characteristics
| MR Unsafe | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 63828 | Dental suction system activation valve |
An electrically-powered device intended to be permanently integrated within a dental suction system, between the pump and the suction handpiece, to open (activate) and close the suction line between uses. It includes an electronic switching mechanism which allows the valve to be opened using the vacuum generated by the pump.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| EHZ | Evacuator, oral cavity |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c8b4a77b-da79-47ed-aa35-c06bf12db8c2
March 07, 2025
1
February 27, 2025
March 07, 2025
1
February 27, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined