Identity
- Trade Name
- Best Precision Stepper FDA UDI
- Generic Name
- Medical table clamp FDA UDI
- Device Name
- The Precision Stepper is designed to hold and manipulate an ultrasound rectal probe during prostate therapy. The Precision Stepper is used for assisting the physician in placement of the Ultrasound Transducer and Brachytherapy needles for prostate brachytherapy procedures. The Precision Stepper is intended to be mounted onto a stabilizing device such as the Best Precision Stabilizer FDA UDI
- Model / Reference
- C-0000939 FDA UDI
- Description
- The Precision Stepper is designed to hold and manipulate an ultrasound rectal probe during prostate therapy. The Precision Stepper is used for assisting the physician in placement of the Ultrasound Transducer and Brachytherapy needles for prostate brachytherapy procedures. The Precision Stepper is intended to be mounted onto a stabilizing device such as the Best Precision Stabilizer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852656007083 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
Best Precision Stepper 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:
- 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, 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 aa5ddc54-6b72-411f-a7e2-fadb795179db 35 fields · synced May 31, 2026