Identity
- Trade Name
- ROEKO Surgitip FDA UDI
- Generic Name
- Dental suction system cannula, single-use FDA UDI
- Model / Reference
- 462049 FDA UDI
Identifiers
- Catalog Number
- 462049 FDA UDI
- Primary DI / UDI-DI
- E1654620490 FDA UDI
- FDA Product Code
- JOL FDA UDI
- GMDN Term
- Dental suction system cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6.5 Millimeter FDA UDI
Category: Dental suction system cannula, single-use
ROEKO Surgitip by Coltène/Whaledent AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Coltène/Whaledent AG
Sources (1)
- FDA UDI 04f23f0b-d43a-431d-9285-03225eef8cad 36 fields · synced May 30, 2026