Sage
by Sage Products LLC 22 variants
Ref 6714-XModel 08858250000253RJ
Sage (6714-X) is a Class IIa device made by Sage Products LLC, registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI 08858250000253RJ), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08858250000253RJ 00618029830906 | Date21 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 08858250000253RJ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Class IIA Oral Care Procedure Packs
- Model / reference
- 08858250000253RJ, 6714-X
- Primary DI / UDI-DI
- 00618029830906
- Basic UDI-DI
- 08858250000253RJ
- EMDN code
- Q010599 Dental instruments, single-use - other
- Device class
- Class IIa
- System or procedure pack
- Procedure pack
- EU registration type
- System or procedure pack
- Medical purpose
- Zum Gebrauch an Patienten, die nicht expektorieren können. Benutzung als Teil eines umfassenden Mundpflegeprotokolls, um das Risiko einer nosokomialen Pneumonie (HAP) und Beatmungspneumonie (VAP) zu senken. Gebrauch unter Anleitung einer medizinischen Fachkraft. Bietet ausreichende Saugstärke, um den vorgesehenen Zweck zu erfüllen.
Manufacturer details
- EUDAMED SRN
- US-PR-000046450
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