Identity
- Trade Name
- Straight Shank, FP, 0.89 mm EUDAMEDNA FDA UDI
- Generic Name
- Tympanostomy tube FDA UDI
- Device Name
- Otological Ventilation Tubes EUDAMED
- Model / Reference
- VT-0903-01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00385640001724 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00385640001724 EUDAMED
- 510(k) Number
- K830228 FDA UDI
- FDA Product Code
- ETD FDA UDI
- EMDN Code
- Q03040199 EAR DRAINAGE AND VENTILATION DEVICES - OTHER EUDAMED
- GMDN Term
- Tympanostomy tube FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3880 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Straight Shank, FP, 0.89 mm by Summit Medical, LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00385640001724 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Summit Medical, LLC
- EUDAMED SRN
- US-MF-000026771
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 3e9d090a-8165-4518-af82-7c15f0672170 61 fields · synced Jun 17, 2026
- FDA UDI 8906b09c-4ac0-49da-99a5-cb1cfb4f1189 34 fields · synced May 29, 2026