Identity
- Trade Name
- Capintec Dose Calibrator FDA UDI
- Generic Name
- Radioisotope calibration system FDA UDI
- Device Name
- Radioisotope Dose Calibrator FDA UDI
- Model / Reference
- CRC-25PET FDA UDI
- Description
- Radioisotope Dose Calibrator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859942006041 FDA UDI
- 510(k) Number
- K071396 FDA UDI
- FDA Product Code
- KPT FDA UDI
- GMDN Term
- Radioisotope calibration system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1360 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: Radioisotope calibration system
Capintec Dose Calibrator by Mirion Technologies (capintec), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radioisotope calibration system.
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- Atomlab 500 Plus — Biodex Medical Systems · Class II
- Capintec Dose Calibrator — MIRION TECHNOLOGIES (CAPINTEC), INC · Class II
- Capintec Dose Calibrator — MIRION TECHNOLOGIES (CAPINTEC), INC · Class II
Cleared under the same submission
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
- Mirion Technologies (capintec), Inc
Sources (1)
- FDA UDI 26aaaa26-7e5f-4dce-abf1-fcdf94b403aa 34 fields · synced May 30, 2026