Identity
- Trade Name
- Cradle, Sonalis-NG FDA UDI
- Generic Name
- Medical table clamp FDA UDI
- Device Name
- The Sonalis-NG Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Sonalis-NG Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers. FDA UDI
- Model / Reference
- 210509 FDA UDI
- Description
- The Sonalis-NG Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Sonalis-NG Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852656007489 FDA UDI
- 510(k) Number
- K973786 FDA UDI
- FDA Product Code
- IWJ FDA UDI
- GMDN Term
- Medical table clamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.5650 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medical table clamp
Cradle, Sonalis-NG by Best Nomos — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K973786 also covers:
- Best Precision Stepper — Best Nomos
- Cradle, Aloka — Best Nomos
- Cradle, BK 8551 — Best Nomos
- Cradle, BK 8558 and BK 8658 — Best Nomos
- Cradle, BK 8848 — Best Nomos
- Cradle, GE ERB — Best Nomos
- Cradle, Hitachi — Best Nomos
- Cradle, Siemens — Best Nomos
- Cradle, Sonalis — Best Nomos
- Cradle, SonoScape — Best Nomos
- Disposable Template, 17 Gauge, Non-Siemens, 5 Pack — Best Nomos
- Disposable Template, 17 Gauge, Non-Siemens, Single — Best Nomos
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Best Nomos
Sources (1)
- FDA UDI 028a77f5-db7c-4481-87e3-cf90b03627ba 35 fields · synced May 30, 2026