Identity
- Trade Name
- Hyper LT FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI
- Device Name
- Hard Tissue Curette Handpiece without Tip, 25 kHz FDA UDI
- Model / Reference
- 5450811000 FDA UDI
- Description
- Hard Tissue Curette Handpiece without Tip, 25 kHz FDA UDI
Identifiers
- Catalog Number
- 5450-811-000 FDA UDI
- Primary DI / UDI-DI
- 07613327291957 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDI
Classification
- Device Class
- U 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Soft-tissue ultrasonic surgical system handpiece, reusable
Hyper LT by Stryker Medtech K.k. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue ultrasonic surgical system handpiece, reusable.
- Handlike — Hunan Handlike Minimally Invasive Surgery Co., Ltd. · U
- MS-Pen — Söring GmbH · Class II
- neXus — Misonix, LLC · U
- UAW Instrument — Söring GmbH · U
- UAW Instrument — Söring GmbH · U
- CUSA® Excel — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
- CUSA® Clarity — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
- SonaStar — Misonix, LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Medtech K.k.
Sources (1)
- FDA UDI 12cf8193-a747-4615-9916-71208e55b8ec 36 fields · synced May 30, 2026