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Reusable Frame, Bard SurePoint Stepper
FDA UDIClass I (US FDA UDI)
by Best Nomos
Identity
- Trade Name
- Reusable Frame, Bard SurePoint Stepper FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- The Bard SurePoint Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures. FDA UDI
- Model / Reference
- 6051 FDA UDI
- Description
- The Bard SurePoint Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852656007182 FDA UDI
- 510(k) Number
- K973786 FDA UDI
- FDA Product Code
- IWJ FDA UDI
- GMDN Term
- Needle guide, reusable 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: Needle guide, reusable
Reusable Frame, Bard SurePoint Stepper by Best Nomos — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, reusable.
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- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- Duckworth & Kent — DUCKWORTH AND KENT LIMITED · Class I
- MP-2794-G16 — FUJIFILM Corporation · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
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, Sonalis-NG — Best Nomos
- Cradle, SonoScape — Best Nomos
- Disposable Template, 17 Gauge, Non-Siemens, 5 Pack — 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 |
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Manufacturer
- Manufacturer
- Best Nomos
Sources (1)
- FDA UDI d58276d9-f90d-4b31-a089-dfc9edf91ef3 35 fields · synced May 30, 2026