Identity
- Trade Name
- CUSA® Selector® FDA UDI
- Generic Name
- Ultrasonic surgical system flue FDA UDI
- Device Name
- CUSA® Selector® 24kHz Laparascopic Flue (Pack of 10) FDA UDI
- Model / Reference
- 1523032 FDA UDI
- Description
- CUSA® Selector® 24kHz Laparascopic Flue (Pack of 10) FDA UDI
Identifiers
- Catalog Number
- 1523032 FDA UDI
- Primary DI / UDI-DI
- 10381780040682 FDA UDI
- 510(k) Number
- K021989 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Ultrasonic surgical system flue FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CUSA® Selector® by Integra Lifesciences (ireland) Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K021989 also covers:
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
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
- Integra Lifesciences (ireland) Limited
Sources (1)
- FDA UDI 6392adcb-9495-4a8e-b24a-df39ba9e2ae0 39 fields · synced Jun 8, 2026