Disposable infection control barrier
by Minitube AB EUDAMEDGUDID
Active
Ref 403062
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number07350069421579 | Date1 Apr 2025 | StatusListed |
| European Union | CE/MDR EUDAMED | Number++B9764000006K | Date15 Dec 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- C20 Intraoral Protective Sheaths
- Generic Name
- Medical equipment/instrument drape, single-use
- Device Name
- Disposable infection control barrier
- Model / Reference
- 403062
- Primary DI / UDI-DI
- 07350069421579
- Basic UDI-DI
- ++B9764000006K
- Unit of Use DI
- 07350069420572
- 510(k) Number
- FDA Product Code
- PEM
- EMDN Code
- T030102 Cover sheaths, instruments and equipments
- GMDN Term
- Medical equipment/instrument drape, single-use
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 878.4370
- Market of Registration
- France
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- SE-MF-000002089
Other devices from Minitube AB
Properties
Other properties (19)
- Sterile: No
- Implantable: No
- Reusable: 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
- Premarket Exempt: No
- Expiration Date: No