FDA product code NRV

Implantable Radio Frequency Transponder System

General Hospital·Class 2·21 CFR 880.6300·Implantable
US regulatory classifications
US Product Code (FDA)
NRV
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.6300
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

An implantable microtransponder system intended to facilitate access to identification and health information in humans. It is described as consisting of a small implantable electronic microtransponder, an insertion device (introducer), and an electronic scanner (pocket reader). The microtransponder is a passive device that contains an electronic circuit, which is activated externally by a low-powered radio beam sent by a handheld, battery-powered pocket reader. The microtransponder stores only a unique electronic identification number (id). The id number is used to access a database that provides the implanted person's identity and health information supplied by the patient

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About this record

Implantable Radio Frequency Transponder System is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.