Identity
- Trade Name
- STERIZONE® CI+ Chemical indicator FDA UDI
- Generic Name
- Chemical/physical sterilization process indicator FDA UDI
- Device Name
- The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indicator, which distinguishes between processed and unprocessed medical device packages, intended for sterilization using the STERIZONE® VP4 Sterilizer. FDA UDI
- Model / Reference
- 43810-1 FDA UDI
- Description
- The STERIZONE® CI+ Chemical Indicator (CI+) is a Type 1 (Class 1) process indicator, which distinguishes between processed and unprocessed medical device packages, intended for sterilization using the STERIZONE® VP4 Sterilizer. FDA UDI
Identifiers
- Catalog Number
- 43810-1 FDA UDI
- Primary DI / UDI-DI
- 00690455438109 FDA UDI
- 510(k) Number
- K141698 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
No
FDA UDI
Category: Chemical/physical sterilization process indicator
STERIZONE® CI+ Chemical indicator by Tso3, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chemical/physical sterilization process indicator.
- 3M™ Attest™ — 3M COMPANY · Class II
- Comply™ — 3M COMPANY · Class II
- VERISURE™ — TERRAGENE S.A. · Class II
- Comply™ SteriGage™ — 3M COMPANY · Class II
- AICON — AESCULAP, INC. · Class II
- VERIFY — Albert Browne , Ltd. · Class II
- VERISURE™ — TERRAGENE S.A. · Class II
- AESCULAP — AESCULAP, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tso3, Inc.
Sources (1)
- FDA UDI d071fc4d-56cf-491b-9bdf-db49aeb5043c 37 fields · synced May 30, 2026