Identity
- Trade Name
- GammaPro Angled Standard Probe FDA UDI
- Generic Name
- Mobile gamma camera system FDA UDI
- Device Name
- GammaPro Angled Standard Probe used for wireless ionizing radiation detection. FDA UDI
- Model / Reference
- K0021C01 FDA UDI
- Description
- GammaPro Angled Standard Probe used for wireless ionizing radiation detection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B619GPROSTDANGPROBE0 FDA UDI
- FDA Product Code
- IZD FDA UDI
- GMDN Term
- Mobile gamma camera system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1320 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mobile gamma camera system
GammaPro Angled Standard Probe by Kubtec — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mobile gamma camera system.
- GammaPro Laparoscopic Probe with Tablet and Carry Case — Kubtec · Class I
- GammaPro Standard Probe with Tablet Carry Case — Kubtec · Class I
- GammaPro High Sensitivity Probe — Kubtec · Class I
- GammaPro Straight Standard Probe — Kubtec · Class I
- GammaPro Hi-Sense Probe with Tablet and Carry Case — Kubtec · Class I
- GammaPro Angled Standard Probe — Kubtec · Class I
- GammaPro Laparoscopic Probe — Kubtec · Class I
- GammaPro Laparoscopic Probe — Kubtec · Class I
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
- Kubtec
Sources (1)
- FDA UDI 4b91d191-7724-4b8c-bd13-ffb9776f002f 33 fields · synced Jun 6, 2026