FDA UDI
In Commercial Distribution
🇺🇸 United States
AssureCheck™
DI: 10686864061233
·
Model: ST0005
·
TERRAGENE S.A.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
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Basic Information
- Brand Name
- AssureCheck™
- Primary DI
- 10686864061233
- Version / Model
- ST0005
- Company Name
- TERRAGENE S.A.
- Labeler DUNS
- 970856911
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2025-10-16
- Public Version
- 1
- Public Version Date
- 2025-10-24
- Public Version Status
- New
- Public Device Record Key
- 65f0cdc6-22e6-473e-a016-8e3a9a2ef4c0
Device Description
AssureCheck™ Type 5 Chemical Indicator for monitoring steam sterilization processes
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35362 | Chemical/physical sterilization process indicator | A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20686864061230 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10686864061233 | GS1 | ||||
| Unit of Use | 00686864061236 | GS1 |
Customer Contacts
- Phone
- 1-800-361-2862
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity