← Back to catalogue

Integron®

FDA UDI

Class II (US FDA UDI)

by Terragene S.a.

Identity

Trade Name
Integron® FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
Chemical Integrator For Ethylene Oxide sterilization processes. FDA UDI
Model / Reference
IT12 FDA UDI
Description
Chemical Integrator For Ethylene Oxide sterilization processes. FDA UDI

Identifiers

Primary DI / UDI-DI
07798164672319 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

Integron® by Terragene S.a. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemical/physical sterilization process indicator.

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
Terragene S.a.

Sources (1)

  • FDA UDI 2e020f3e-e5c2-4829-8a05-d30f71871f3c 35 fields · synced Jun 8, 2026