Identity
- Trade Name
- Cradle, Hitachi FDA UDI
- Generic Name
- Medical table clamp FDA UDI
- Device Name
- The Hitachi Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Hitachi 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
- 6056 FDA UDI
- Description
- The Hitachi Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Hitachi 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
- 00852656007113 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, Hitachi 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, Siemens — Best Nomos
- Cradle, Sonalis — Best Nomos
- Cradle, Sonalis-NG — 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 40dc14c3-7a23-417a-bd4b-800da803c1db 35 fields · synced May 30, 2026