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trophon AcuTrace Medical Instrument Tag

FDA UDIEUDAMED

Class I (US FDA UDI)

by Nanosonics, Inc.

Identity

Trade Name
trophon AcuTrace Medical Instrument Tag FDA UDI
Generic Name
Device operating status label/tag, reusable FDA UDI
Device Name
RFID Medical Instrument tag FDA UDI
Model / Reference
N05007 FDA UDI
Description
RFID Medical Instrument tag FDA UDI

Identifiers

Primary DI / UDI-DI
09350855000214 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Device operating status label/tag, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Device operating status label/tag, reusable

trophon AcuTrace Medical Instrument Tag by Nanosonics, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Device operating status label/tag, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nanosonics, Inc.

Sources (2)

  • FDA UDI 08bae26d-3546-4c9c-aba3-3bfbc8e5ec07 33 fields · synced Jun 17, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026