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Disposable Template, 18 Gauge, Siemens, Single
FDA UDIClass I (US FDA UDI)
by Best Nomos
Identity
- Trade Name
- Disposable Template, 18 Gauge, Siemens, Single FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures. FDA UDI
- Model / Reference
- 6105 FDA UDI
- Description
- The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852656007342 FDA UDI
- 510(k) Number
- K973786 FDA UDI
- FDA Product Code
- IWJ FDA UDI
- GMDN Term
- Needle guide, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Needle guide, single-use
Disposable Template, 18 Gauge, Siemens, Single by Best Nomos — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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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, 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 2892a8be-8e83-4f14-9ba2-2993c37e9cea 35 fields · synced Jun 8, 2026