Identity
- Trade Name
- TendoNova Ocelot FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
- Device Name
- TendoNova Disposable Unit 60mm Kit FDA UDI
- Model / Reference
- DU5F60L-K FDA UDI
- Description
- TendoNova Disposable Unit 60mm Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009899841 FDA UDI
- 510(k) Number
- K212049 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
Classification
- Device Class
- U 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
No
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
- Length — 60 Millimeter FDA UDI
Category: Patient surgical drape, single-useSkin-cover adhesive strip, non-antimicrobialSkin topical coupling gelSoft-tissue ultrasonic surgical system handpiece tip, single-use
TendoNova Ocelot by TendoNova Corporation — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212049 also covers:
- Ocelot — TendoNova Corporation
- Ocelot — TendoNova Corporation
- Ocelot — TendoNova Corporation
- Ocelot — TendoNova Corporation
- Ocelot — TendoNova Corporation
- Ocelot — TendoNova Corporation
- TendoNova Ocelot — TendoNova Corporation
- TendoNova Ocelot — TendoNova Corporation
- TendoNova Ocelot — TendoNova Corporation
- TendoNova Ocelot — TendoNova Corporation
- TendoNova Ocelot — TendoNova Corporation
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 U | Pending data |
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Manufacturer
- Manufacturer
- TendoNova Corporation
Sources (1)
- FDA UDI a1a6fd38-ed23-47c5-a574-28732d5691e5 35 fields · synced May 30, 2026