Stoma® 4034.02
Ref 4034.02Model 13380 - Hand-held dental retractor (007)
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++ESAM0078S +ESAM4034021 | Date5 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number+ESAM4034021 | Date27 Aug 2020 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Vestibulumhaken, mit Stegen EUDAMEDStoma® GUDID
- Generic Name
- Hand-held dental retractor
- Model / Ref / Catalog
- 4034.02, 13380 - Hand-held dental retractor (007)
- Primary DI / UDI-DI
- +ESAM4034021 EUDAMEDESAM4034021 GUDID
- Basic UDI-DI
- ++ESAM0078S
- FDA Product Code
- EIG
- EMDN Code
- L03140199 Spreaders and retractors for general surgery, reusable - other
- GMDN Term
- Hand-held dental retractor
- Device Class
- Class I
- Regulation Number
- 872.4565
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | +ESAM4034021 | ESAM4034021 |
Other devices from Storz am Mark GmbH
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No