Identity
- Trade Name
- Sure-Point™ FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- Sure-Point™ Tracker FDA UDI
- Model / Reference
- D0136200 FDA UDI
- Description
- Sure-Point™ Tracker FDA UDI
Identifiers
- Catalog Number
- D0136200 FDA UDI
- Primary DI / UDI-DI
- 00801741078897 FDA UDI
- 510(k) Number
- K030518 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
Yes
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
Category: General-purpose brachytherapy system applicator, manual
Sure-Point™ by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose brachytherapy system applicator, manual.
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Cleared under the same submission
K030518 also covers:
- Brachy Needle Box — C. R. Bard, Inc.
- Brachy Needle Loading Shield — C. R. Bard, Inc.
- Brachy Probe Cradle 3G Simulview Tracker — C. R. Bard, Inc.
- Brachy Probe Cradle Tracker Aloka — C. R. Bard, Inc.
- Brachy Probe Cradle Tracker B-K 8558 — C. R. Bard, Inc.
- Brachy Probe Cradle Tracker B-K 8848 — C. R. Bard, Inc.
- Brachy Probe Cradle Tracker Hitachi — C. R. Bard, Inc.
- Brachy Probe Cradle Tracker Siemens — C. R. Bard, Inc.
- Sure-Point™ — C. R. Bard, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
Sources (1)
- FDA UDI 45670069-ccd4-4a31-81a8-080c7a23c67a 36 fields · synced Jun 6, 2026