Identity
- Trade Name
- Invuity® Steam Sterilization Tray FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- The Invuity Steam Sterilization Tray is intended to allow sterilization of the enclosed medical devices. FDA UDI
- Model / Reference
- 1.5 x 10 x 15 in FDA UDI
- Description
- The Invuity Steam Sterilization Tray is intended to allow sterilization of the enclosed medical devices. FDA UDI
Identifiers
- Catalog Number
- 11185 FDA UDI
- Primary DI / UDI-DI
- 00816728020295 FDA UDI
- 510(k) Number
- K090070 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 15 Inch FDA UDIWidth — 10 Inch FDA UDIHeight — 1.5 Inch FDA UDI
Category: Device sterilization/disinfection container, reusable
Invuity® Steam Sterilization Tray by Invuity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K090070 also covers:
- Breiten Sterilization Tray — INVUITY, INC.
- Breiten Sterilization Tray — INVUITY, INC.
- Eigr™ Waveguide — INVUITY, INC.
- Eikon Sterilization Tray — INVUITY, INC.
- Invuity® Fiber Optic Cable — INVUITY, INC.
- Invuity® Fiber Optic Cable — INVUITY, INC.
- Invuity® Fiber Optic Sterilization Tray — INVUITY, INC.
- Invuity® Steam Sterilization Tray — INVUITY, INC.
- Invuity® Sterilization Tray — INVUITY, INC.
- Synthes Fiber Optic Cable — INVUITY, INC.
- Synthes Fiber Optic Cable — INVUITY, INC.
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
- Invuity, Inc.
Sources (1)
- FDA UDI 22811636-24af-45d4-82db-3171abb602fb 37 fields · synced May 30, 2026