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Verichip Health Information Microtransponder And Pocket Reader

by Digital Angel Corporation

De Novo DEN040007

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Post-NSE NumberDEN040007 Date12 Oct 2004DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
NRV
Device Class
Class II
Regulation
21 CFR Part 880.6300
Advisory Committee
General Hospital
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Verichip Health Information Microtransponder And Pocket Reader is an Implantable Radio Frequency Transponder System, which is a type of device that uses radio frequency to transmit information. It is classified as a device in the General Hospital medical specialty. The device consists of a microtransponder and a pocket reader. The microtransponder is implantable, while the pocket reader is used to read the information from the microtransponder.

The Verichip Health Information Microtransponder And Pocket Reader is supplied with a product code of NRV and a regulation number of 880.6300. It has been assigned a k number of DEN040007 and an fei number of 3030516433. The device is classified as a class 2 device. It is intended for use in a general hospital setting, with an advisory committee description of General Hospital. The device has received FDA 510K authorization.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Verichip Microtransponder System used for?

    The Verichip Microtransponder System is used to transmit health information in a general hospital setting.

  • Is the Verichip Microtransponder System implantable?

    Yes, the microtransponder is implantable, while the pocket reader is used to read the information from the microtransponder.

  • What is the regulatory classification of the Verichip Microtransponder System?

    The device is classified as a class 2 device with an FDA 510K authorization.