← Back to catalogue

Trophon Chemical Indicator

FDA UDI

Class II (US FDA UDI)

by Nanosonics, Inc.

Identity

Trade Name
Trophon Chemical Indicator FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT) FDA UDI
Model / Reference
N00091 FDA UDI
Description
Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT) FDA UDI

Identifiers

Primary DI / UDI-DI
09350855000047 FDA UDI
510(k) Number
K103126 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Chemical/physical sterilization process indicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Chemical/physical sterilization process indicator

Trophon Chemical Indicator by Nanosonics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Cleared under the same submission

K103126 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nanosonics, Inc.

Sources (1)

  • FDA UDI 309f56f0-09ce-491e-8383-7443cc3a550e 34 fields · synced Jun 8, 2026